中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600125080
最近更新日期： Date of Last Refreshed on：	2026-05-21 10:10:44
注册时间： Date of Registration：	2026-05-21 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	单中心、随机、双盲、安慰剂对照，评价 HEC-007 注射液在健康受试者中单次给药和在超重或肥胖受试者中多次给药的安全性、耐受性、药代动力学及药效学的Ⅰ期临床试验
Public title：	A single-centre, randomised, double-blind, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC-007 injection in healthy subjects administered as a single dose and in overweight or obese subjects administered as multiple doses
注册题目简写：
English Acronym：
研究课题的正式科学名称：	单中心、随机、双盲、安慰剂对照，评价 HEC-007 注射液在健康受试者中单次给药和在超重或肥胖受试者中多次给药的安全性、耐受性、药代动力学及药效学的Ⅰ期临床试验
Scientific title：	A single-centre, randomised, double-blind, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC-007 injection in healthy subjects administered as a single dose and in overweight or obese subjects administered as multiple doses
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	刘慧敏	研究负责人：	胡伟
Applicant：	Liu Huimin	Study leader：	Hu Wei
申请注册联系人电话： Applicant telephone：	+86 15927102714	研究负责人电话： Study leader's telephone：	+86 551 65997164
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	liuhuimin@hec.cn	研究负责人电子邮件： Study leader's E-mail：	ayefygcp@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	中国广东省东莞市南城区鸿福路100号东莞东阳光科技大厦15楼	研究负责人通讯地址：	中国安徽省合肥市蜀山区芙蓉路678号
Applicant address：	15th Floor, Dongguang Technology Building, No. 100 Hongfu Road, Nancheng District, Dongguan, Guangdong, China	Study leader's address：	678 Furong Road, Shushan District, Hefei, Anhui, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	东莞市东阳光生物药研发有限公司
Applicant's institution：	Dongguan Dongyangguang Biopharmaceutical R&D Co.
研究负责人所在单位：	安徽医科大学第二附属医院
Affiliation of the Leader：	The Second Hospital of Anhui Medical University

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	YW2025-175	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	安徽医科大学第二附属医院伦理委员会
Name of the ethic committee：	The Second Hospital of Anhui Medical University,Ethics Committee Office Action
伦理委员会批准日期： Date of approved by ethic committee：	2025-08-22 00:00:00
伦理委员会联系人：	张静
Contact Name of the ethic committee：	Zhang Jing
伦理委员会联系地址：	中国安徽省合肥市蜀山区芙蓉路678号
Contact Address of the ethic committee：	678 Furong Road, Shushan District, Hefei, Anhui, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 551 63806098	伦理委员会联系人邮箱： Contact email of the ethic committee：	84957813@qq.com

研究实施负责（组长）单位：

安徽医科大学第二附属医院

Primary sponsor：

The Second Hospital of Anhui Medical University

研究实施负责（组长）单位地址：

中国安徽省合肥市蜀山区芙蓉路678号

Primary sponsor's address：

678 Furong Road, Shushan District, Hefei, Anhui, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	安徽	市(区县)：
Country：	China	Province：	Anhui	City：
单位(医院)：	安徽医科大学第二附属医院	具体地址：	中国安徽省合肥市蜀山区芙蓉路678号
Institution hospital：	The Second Hospital of Anhui Medical University	Address：	678 Furong Road, Shushan District, Hefei, Anhui, China

经费或物资来源：

东莞市东阳光生物药研发有限公司

Source(s) of funding：

Dongguan Dongyangguang Biopharmaceutical R&D Co.

研究疾病：

超重，肥胖， 2 型糖尿病

Target disease：

Overweight, obesity, type 2 diabetes

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要目的: 1. 评价HEC-007注射液在健康受试者中单次给药和在超重或肥胖受试者中多次给药的安全性和耐受性； 2. 评价HEC-007注射液在健康受试者中单次给药和在超重或肥胖受试者中多次给药的药代动力学特征； 3. 评价HEC-007注射液在健康受试者中单次给药和在超重或肥胖受试者中多次给药的药效学特征。次要目的: 评价HEC-007注射液在健康受试者中单次给药和在超重或肥胖受试者中多次给药的免疫原性。

Objectives of Study：

Primary Objectives: 1 To evaluate the safety and tolerability of HEC-007 Injection following single administration in healthy subjects and following multiple administration in overweight or obese subjects; 2 To evaluate the pharmacokinetic characteristics of HEC-007 Injection following single administration in healthy subjects and following multiple administration in overweight or obese subjects; 3 To evaluate the pharmacodynamic characteristics of HEC-007 Injection following a single dose in healthy subjects and multiple doses in overweight or obese subjects. Secondary Objectives: To evaluate the immunogenicity of HEC-007 Injection following a single dose in healthy subjects and multiple doses in overweight or obese subjects.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. SAD1: The subject understands and complies with the research procedures, participates voluntarily, and signs the informed consent form;
2. SAD2: Healthy adult subjects aged 18 to 45 inclusive, of either sex;
3. SAD3: Male subjects must weigh no less than 50kg, female subjects no less than 45kg. Body Mass Index (BMI) = weight (kg) / height^2 (m^2), with BMI falling within the range of 19.0 to 35.0 kg/m^2 (including boundary values);
4. SAD4: Vital signs, physical examination, laboratory tests, and results of electrocardiogram, chest CT scan, abdominal ultrasound (liver, gallbladder, spleen, pancreas, both kidneys), thyroid ultrasound, etc., were normal or deemed by the investigator to be abnormal but without clinical significance;
5. SAD5: Female subjects with potential fertility or male subjects must agree to use effective contraception from the date of signing the informed consent form until 6 months after the last dose of the investigational medicinal product, to avoid pregnancy or causing pregnancy in their partner, and must have no plans for sperm donation, egg donation, or pregnancy;
6. SAD6: Screening period glycated haemoglobin (HbA1c) < 5.7%.
7. MAD1: Subjects understood and complied with the research procedures, participated voluntarily, and signed the informed consent form;
8. MAD2: Age range 18 to 65 inclusive; open to both men and women.
9. MAD3: Obesity: BMI > 28.0 kg/m^2; or overweight: 24.0 < BMI < 28.0 kg/m^2, and exhibiting at least one of the following manifestations: prediabetes (see 14.4 for details), hypertension, dyslipidaemia, fatty liver, weight-bearing joint pain, obesity-induced dyspnoea or obstructive sleep apnoea syndrome;
10. MAD4: During screening, weight change must be less than 5% when relying solely on dietary and exercise control for at least 12 weeks.
11. MAD5: Female subjects with potential fertility or male subjects must agree to use effective contraception from the date of signing the informed consent form until six months after the last dose of investigational medicinal product, to avoid pregnancy or causing pregnancy in their partner, and must have no plans for sperm donation, egg donation, or pregnancy.
12. MAD6: Screening criteria: Glycated haemoglobin (HbA1c) < 6.5%.

排除标准：

1. SAD1: 筛选前诊断为1型、2型或其他类型糖尿病； 2. SAD2: 筛选时有甲状腺髓样癌（MTC）、甲状腺C细胞增生或2型多发性内分泌腺瘤综合征（MEN2）病史或家族史，或遗传性疾病容易诱导甲状腺髓样癌者； 3. SAD3: 筛选时有急性或慢性或疑似胰腺炎，或已行胰腺切除术者； 4. SAD4: 筛选前5年内患有任何恶性肿瘤（已接受治愈性治疗并视为治愈的基底细胞癌除外）； 5. SAD5: 筛选时受试者存在有临床意义的下列疾病（包括但不限于胃肠道、肾、肝、神经、血液、内分泌、肿瘤、肺、免疫、精神或心脑血管疾病）； 6. SAD6: 筛选时有影响胃排空或影响胃肠道营养物质吸收的疾病或情况； 7. SAD7: 筛选前3个月内进行过重大手术者，或计划研究期间进行手术者； 8. SAD8: 对试验用药品或其任何成分有过敏史或过敏体质（两种或两种以上药物及食物过敏）者； 9. SAD9: 筛选前3个月内，使用过且经研究者判定明显影响体重、血糖的药物（包括处方药、非处方药、中草药、保健品等）； 10. SAD10: 筛选前接受过减肥手术者； 11. SAD11: 有易复发的皮肤疾病史（荨麻疹等），或给药部位有皮损者； 12. SAD12: 筛选前3个月内接受过慢性（持续超过2周）全身性糖皮质激素治疗（不包括局部、眼内、鼻内、关节内或吸入制剂），或在筛选前1个月内接受过全身性糖皮质激素治疗； 13. SAD13: 筛选时女性受试者的血红蛋白<110g/L，男性受试者的血红蛋白<120g/L，或任何其他已知干扰HbAlc检测的情况； 14. SAD14: 筛选前6个月内有自杀行为或意念者； 15. SAD15: 筛选前6个月内使用过GLP-1R、GLP-1R/GIPR、GLP-1R/GCGR、GLP-1R/GIPR/GCGR激动剂者； 16. SAD16: 筛选前3个月内经常饮酒者，即每周饮酒超过14个单位酒精（1单位=360mL啤酒或45mL酒精量为40%的烈酒或150mL葡萄酒）；或筛选期内血液酒精检测异常有临床意义者；或不能遵守方案中禁止饮酒规定者； 17. SAD17: 筛选前2年内有药物滥用史或使用过毒品者或给药前尿药筛查阳性者； 18. SAD18: 筛选前3个月每日吸烟超过5支或者药代动力学密集采血期间不能放弃吸烟者； 19. SAD19: 有晕针晕血史、不能耐受静脉穿刺采血者以及采血困难者； 20. SAD20: 乙型肝炎表面抗原（HBsAg）和/或丙型肝炎病毒（HCV）抗体和/或人类免疫缺陷病毒（HIV）抗体和/或梅毒螺旋体特异性抗体检查结果为阳性者； 21. SAD21: 筛选时谷丙转氨酶>1.5×正常值上限（ULN），或谷草转氨酶>1.5×ULN，或碱性磷酸酶>1.5×ULN，或总胆红素>1.5×ULN； 22. SAD22: 筛选时血淀粉酶或脂肪酶>正常范围上限（ULN）； 23. SAD23: 筛选时血清降钙素≥20ng/L； 24. SAD24: 筛选时空腹血糖>6.1 mmol/L或<3.9 mmol/L； 25. SAD25: 筛选时肾小球滤过率（GFR）<90 mL/min/1.73 m^2； 26. SAD26: 筛选时12导联心电图经Fridericia公式校正的QT间期（QTcF-QT/RR^0.33）>450 ms（男性）或>470 ms（女性）； 27. SAD27: 在首次用药前4周内服用过肝代谢酶（CYP1A2、2A6、2C8、2C19、3A4和3A5）的强抑制剂和/或诱导剂，肝代谢酶强抑制剂如：环丙沙星、氯吡格雷、伊曲康唑、酮康唑、利托那韦、醋竹桃霉素等，肝代谢酶强诱导剂如：利福平、卡马西平、苯妥英钠、圣约翰草等； 28. SAD28: 在首次用药前2周内服用了任何处方药、非处方药、任何维生素产品或中草药； 29. SAD29: 在首次用药前48小时内服用过影响CYP3A4、CYP2E1和CYP2D6代谢酶的食物或饮料，如西柚或含有西柚的饮料； 30. SAD30: 在首次用药前48小时内摄取了巧克力、任何含咖啡因或富含黄嘌呤的食物或饮料； 31. SAD31: 筛选前3个月内献血量>200 mL、或有过任何成分献血，或因任何原因导致失血总量>200 mL，或者有输血史，血制品使用史； 32. SAD32: 在筛选前3个月内参加了其他临床试验（如果受试者在治疗前退出研究，即未被随机化或未接受治疗，可以入组本研究）； 33. SAD33: 从签署知情同意书至首次给药前发生急性疾病或有伴随用药； 34. SAD34: 受试者正在哺乳或筛选时妊娠结果阳性； 35. SAD35: 研究者认为具有其他不适宜参加本试验因素的受试者。

Exclusion criteria：

1. SAD1: Diagnosed with type 1, type 2, or other types of diabetes prior to screening; 2. SAD2: Screening for individuals with a personal or family history of medullary thyroid carcinoma (MTC), C-cell hyperplasia of the thyroid, or multiple endocrine neoplasia type 2 (MEN2); or those with hereditary conditions predisposing to medullary thyroid carcinoma; 3. SAD3: Individuals with acute or chronic pancreatitis, suspected pancreatitis, or prior pancreatectomy at the time of screening; 4. SAD4: Screening for any malignant tumour within the preceding five years (excluding basal cell carcinoma that has undergone curative treatment and is considered cured); 5. SAD5: At the time of screening, subjects present with any of the following clinically significant conditions (including but not limited to gastrointestinal, renal, hepatic, neurological, haematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, or cardiovascular diseases); 6. SAD6: Screening for diseases or conditions affecting gastric emptying or gastrointestinal nutrient absorption; 7. SAD7: Exclude individuals who have undergone major surgery within the preceding three months, or who plan to undergo surgery during the study period; 8. SAD8: Individuals with a history of allergy to the investigational medicinal product or any of its constituents, or those with an allergic constitution (allergic to two or more drugs and foods); 9. SAD9: Medications used within the preceding three months that the investigator deems to have significantly impacted body weight or blood glucose levels (including prescription drugs, over-the-counter medications, Chinese herbal medicines, health supplements, etc.); 10. SAD10: Individuals who have undergone weight-loss surgery prior to screening; 11. SAD11: History of skin conditions prone to recurrence (e.g., urticaria), or presence of skin lesions at the administration site; 12. SAD12: Screening exclusion criteria: having received systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled formulations) for chronic conditions (lasting over two weeks) within the preceding three months, or having received systemic glucocorticoid therapy within the preceding month; 13. SAD13: Screening criteria: haemoglobin <110 g/L for female subjects, <120 g/L for male subjects, or any other known condition interfering with HbA1c testing; 14. SAD14: Screen for individuals who have exhibited suicidal behaviour or thoughts within the preceding six months; 15. SAD15: Individuals who have used GLP-1 receptor agonists, GLP-1R/GIPR agonists, GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within the preceding six months prior to screening; 16. SAD16: Exclude individuals who frequently consumed alcohol within the preceding three months, defined as weekly intake exceeding 14 units of alcohol (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); or those with clinically significant abnormal blood alcohol levels during screening; or those unable to comply with the protocol's prohibition on alcohol consumption; 17. SAD17: Exclude individuals with a history of drug use within the preceding two years, those who have used illicit drugs, or those with a positive urine drug screen prior to administration; 18. SAD18: Individuals who smoked more than five cigarettes daily in the three months prior to screening, or who were unable to abstain from smoking during the intensive pharmacokinetic sampling period; 19. SAD19: Individuals with a history of needle phobia or blood phobia, those unable to tolerate venous blood sampling, and those presenting with difficult venipuncture; 20. SAD20: Individuals testing positive for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibody and/or human immunodeficiency virus (HIV) antibody and/or Treponema pallidum-specific antibody; 21. SAD21: Screening criteria: alanine aminotransferase > 1.5 times the upper limit of normal (ULN), or aspartate aminotransferase > 1.5 times ULN, or alkaline phosphatase > 1.5 times ULN, or total bilirubin > 1.5 times ULN; 22. SAD22: Screening blood amylase or lipoprotein levels > upper limit of normal (ULN); 23. SAD23: Serum calcitonin ≥ 20 ng/L at screening; 24. SAD24: Screening criteria: fasting blood glucose >6.1 mmol/L or <3.9 mmol/L; 25. SAD25: Screening criteria: glomerular filtration rate (GFR) < 90 mL/min/1.73 m^2; 26. SAD26: During screening, the QT interval corrected by Fridericia's formula (QTcF-QT/RR^0.33) in a 12-lead electrocardiogram exceeds 450 milliseconds (msec) in males or 470 msec in females; 27. SAD27: Within 4 weeks prior to first administration, patients have taken potent inhibitors and/or inducers of hepatic metabolic enzymes (CYP1A2, 2A6, 2C8, 2C19, 3A4, and 3A5), Strong inhibitors of hepatic metabolic enzymes such as: ciprofloxacin, clopidogrel, itraconazole, ketoconazole, ritonavir, estramustine, etc.; Strong inducers of hepatic metabolic enzymes such as: rifampicin, carbamazepine, phenytoin, St. John's wort, etc. 28. SAD28: Within the two weeks prior to the first dose, the patient has taken any prescription medication, over-the-counter medication, vitamin products, or Chinese herbal remedies. 29. SAD29: Consumption of food or beverages affecting CYP3A4, CYP2E1 and CYP2D6 metabolic enzymes, such as grapefruit or beverages containing grapefruit, within 48 hours prior to the first dose. 30. SAD30: Consumption of chocolate, any caffeinated or purine-rich food or drink within 48 hours prior to the first dose; 31. SAD31: Exclude individuals who, within the preceding three months, have donated more than 200 mL of whole blood, have undergone any form of component donation, have experienced total blood loss exceeding 200 mL for any reason, or have a history of blood transfusion or blood product administration. 32. SAD32: Participation in other clinical trials within the three months preceding screening (if the subject withdrew from the study prior to treatment initiation, i.e., was not randomised or did not receive treatment, they may be enrolled in this study); 33. SAD33: Acute illness or concomitant medication occurring between signing the informed consent form and the first dose administration. 34. SAD34: Subject is breastfeeding or has screened positive for pregnancy; 35. SAD35: Subjects deemed by the investigator to possess other factors rendering them unsuitable for participation in this trial.

研究实施时间：

Study execute time：

从 From 2025-08-19 00:00:00至 To 2026-08-19 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-09-21 00:00:00 至 To 2026-08-19 00:00:00

干预措施：

Interventions：

组别：	第1组（Part A：SAD）	样本量：	4
Group：	Group 1 (Part A: SAD)	Sample size：	4
干预措施：	HEC-007注射液0.1 mg，D1空腹条件下经腹部皮下注射单次给药；4例均接受HEC-007	干预措施代码：
Intervention：	HEC-007 injection 0.1 mg, single abdominal subcutaneous dose on D1 under fasting conditions; all 4 subjects receive HEC-007	Intervention code：

组别：	第2组（Part A：SAD）	样本量：	10
Group：	Group 2 (Part A: SAD)	Sample size：	10
干预措施：	HEC-007注射液0.3 mg，D1空腹条件下经腹部皮下注射单次给药；8例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 0.3 mg, single abdominal subcutaneous dose on D1 under fasting conditions; 8 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第3组（Part A：SAD）	样本量：	10
Group：	Group 3 (Part A: SAD)	Sample size：	10
干预措施：	HEC-007注射液1 mg，D1空腹条件下经腹部皮下注射单次给药；8例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 1 mg, single abdominal subcutaneous dose on D1 under fasting conditions; 8 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第4组（Part A：SAD）	样本量：	10
Group：	Group 4 (Part A: SAD)	Sample size：	10
干预措施：	HEC-007注射液3 mg，D1空腹条件下经腹部皮下注射单次给药；8例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 3 mg, single abdominal subcutaneous dose on D1 under fasting conditions; 8 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第5组（Part A：SAD）	样本量：	10
Group：	Group 5 (Part A: SAD)	Sample size：	10
干预措施：	HEC-007注射液6 mg，D1空腹条件下经腹部皮下注射单次给药；8例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 6 mg, single abdominal subcutaneous dose on D1 under fasting conditions; 8 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第6组（Part A：SAD）	样本量：	10
Group：	Group 6 (Part A: SAD)	Sample size：	10
干预措施：	HEC-007注射液9 mg，D1空腹条件下经腹部皮下注射单次给药；8例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 9 mg, single abdominal subcutaneous dose on D1 under fasting conditions; 8 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第7组（Part B：MAD）	样本量：	12
Group：	Group 7 (Part B: MAD)	Sample size：	12
干预措施：	HEC-007注射液1 mg，每周给药1次，W1-W12连续给药12周，经腹部皮下注射；10例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 1 mg once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection; 10 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第8组（Part B：MAD）	样本量：	12
Group：	Group 8 (Part B: MAD)	Sample size：	12
干预措施：	HEC-007注射液3 mg，每周给药1次，W1-W12连续给药12周，经腹部皮下注射；10例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 3 mg once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection; 10 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第9组（Part B：MAD）	样本量：	12
Group：	Group 9 (Part B: MAD)	Sample size：	12
干预措施：	HEC-007注射液3/6 mg剂量递增：3 mg给药4周，随后6 mg给药8周；每周给药1次，W1-W12连续给药12周，经腹部皮下注射；10例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 3/6 mg dose escalation: 3 mg for 4 weeks followed by 6 mg for 8 weeks; once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection; 10 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第10组（Part B：MAD）	样本量：	12
Group：	Group 10 (Part B: MAD)	Sample size：	12
干预措施：	HEC-007注射液3/6/9 mg剂量递增：3 mg给药4周，随后6 mg给药4周，随后9 mg给药4周；每周给药1次，W1-W12连续给药12周，经腹部皮下注射；10例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 3/6/9 mg dose escalation: 3 mg for 4 weeks, followed by 6 mg for 4 weeks, followed by 9 mg for 4 weeks; once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection; 10 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第11组（Part B：MAD）	样本量：	12
Group：	Group 11 (Part B: MAD)	Sample size：	12
干预措施：	HEC-007注射液3/6/9/12 mg剂量递增：3 mg给药2周，随后6 mg给药2周，随后9 mg给药4周，随后12 mg给药4周；每周给药1次，W1-W12连续给药12周，经腹部皮下注射；10例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 3/6/9/12 mg dose escalation: 3 mg for 2 weeks, followed by 6 mg for 2 weeks, followed by 9 mg for 4 weeks, followed by 12 mg for 4 weeks; once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection; 10 subjects receive HEC-007 and 2 receive placebo	Intervention code：

组别：	第12组（Part B：MAD）	样本量：	12
Group：	Group 12 (Part B: MAD)	Sample size：	12
干预措施：	HEC-007注射液3/6/9/12/15 mg剂量递增：3 mg给药2周，随后6 mg给药2周，随后9 mg给药2周，随后12 mg给药2周，随后15 mg给药4周；每周给药1次，W1-W12连续给药12周，经腹部皮下注射；10例接受HEC-007，2例接受安慰剂	干预措施代码：
Intervention：	HEC-007 injection 3/6/9/12/15 mg dose escalation: 3 mg for 2 weeks, followed by 6 mg for 2 weeks, followed by 9 mg for 2 weeks, followed by 12 mg for 2 weeks, followed by 15 mg for 4 weeks; once weekly from W1 to W12 for 12 weeks by abdominal subcutaneous injection; 10 subjects receive HEC-007 and 2 receive placebo	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	安徽	市(区县)：
Country：	China	Province：	Anhui	City：
单位(医院)：	安徽医科大学第二附属医院	单位级别：	三级甲等
Institution hospital：	The Second Hospital of Anhui Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	Part A SAD试验：体重、腰围、腰臀比	指标类型：	主要指标
Outcome：	Part A SAD trial: body weight, waist circumference, waist-to-hip ratio	Type：	Primary indicator
测量时间点：	基线、给药后3天、8天、15天、29天、43天	测量方法：
Measure time point of outcome：	Baseline, 3 days, 8 days, 15 days, 29 days, and 43 days after dosing	Measure method：

指标中文名：	Part A SAD试验：空腹血糖、空腹胰岛素、空腹C肽、空腹胰高血糖素、脂联素、HOMA-IR	指标类型：	主要指标
Outcome：	Part A SAD trial: fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, adiponectin, HOMA-IR	Type：	Primary indicator
测量时间点：	基线、给药后3天、8天、15天、29天、43天	测量方法：
Measure time point of outcome：	Baseline, 3 days, 8 days, 15 days, 29 days, and 43 days after dosing	Measure method：

指标中文名：	Part A SAD试验：空腹血脂（包括TC、LDL-C、TG、HDL-C）	指标类型：	主要指标
Outcome：	Part A SAD trial: fasting blood lipids (including TC, LDL-C, TG, HDL-C)	Type：	Primary indicator
测量时间点：	基线、给药后3天、8天、15天、29天、43天	测量方法：
Measure time point of outcome：	Baseline, 3 days, 8 days, 15 days, 29 days, and 43 days after dosing	Measure method：

指标中文名：	Part A SAD试验：坐位收缩压、舒张压	指标类型：	主要指标
Outcome：	Part A SAD trial: seated systolic blood pressure, diastolic blood pressure	Type：	Primary indicator
测量时间点：	基线、给药后3天、8天、15天、29天、43天	测量方法：
Measure time point of outcome：	Baseline, 3 days, 8 days, 15 days, 29 days, and 43 days after dosing	Measure method：

指标中文名：	Part A SAD试验：血尿酸	指标类型：	主要指标
Outcome：	Part A SAD trial: serum uric acid	Type：	Primary indicator
测量时间点：	基线、给药后3天、8天、15天、29天、43天	测量方法：
Measure time point of outcome：	Baseline, 3 days, 8 days, 15 days, 29 days, and 43 days after dosing	Measure method：

指标中文名：	Part A SAD试验：血药浓度	指标类型：	主要指标
Outcome：	Part A SAD trial: plasma drug concentration	Type：	Primary indicator
测量时间点：	每个计划采血时间点	测量方法：
Measure time point of outcome：	Each planned blood sampling time point	Measure method：

指标中文名：	Part A SAD试验：主要PK参数（包括但不限于：Cmax、Tmax、Tlast和AUC0-t；如数据允许，还将包括AUC0-168h、AUC0-∞、AUC_%Extrap、λz、t1/2、CL/F、Vz/F等）	指标类型：	主要指标
Outcome：	Part A SAD trial: main PK parameters (including but not limited to Cmax, Tmax, Tlast and AUC0-t; if data permit, AUC0-168h, AUC0-∞, AUC_%Extrap, λz, t1/2, CL/F, Vz/F, etc.)	Type：	Primary indicator
测量时间点：	计划采血时间点	测量方法：
Measure time point of outcome：	Planned blood sampling time points	Measure method：

指标中文名：	Part A SAD试验：药效学指标（包括体重、腰围、腰臀比；空腹血糖、空腹胰岛素、空腹C肽、空腹胰高血糖素、空腹血脂[TC、LDL-C、TG、HDL-C]、脂联素、HOMA-IR；坐位收缩压、舒张压；血尿酸）	指标类型：	次要指标
Outcome：	Part A SAD trial: pharmacodynamic indicators (including body weight, waist circumference, waist-to-hip ratio; fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, fasting blood lipids [TC, LDL-C, TG, HDL-C], adiponectin, HOMA-IR; seated systolic blood pressure, diastolic blood pressure; serum uric acid)	Type：	Secondary indicator
测量时间点：	基线及给药后	测量方法：
Measure time point of outcome：	Baseline and after dosing	Measure method：

指标中文名：	Part B MAD试验：体重	指标类型：	主要指标
Outcome：	Part B MAD trial: body weight	Type：	Primary indicator
测量时间点：	治疗12周后	测量方法：
Measure time point of outcome：	After 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：体重	指标类型：	次要指标
Outcome：	Part B MAD trial: body weight	Type：	Secondary indicator
测量时间点：	治疗4、8周后	测量方法：
Measure time point of outcome：	After 4 and 8 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：腰围、腰臀比	指标类型：	次要指标
Outcome：	Part B MAD trial: waist circumference, waist-to-hip ratio	Type：	Secondary indicator
测量时间点：	治疗4、8、12周后	测量方法：
Measure time point of outcome：	After 4, 8, and 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：空腹血糖、空腹胰岛素、空腹C肽、空腹胰高血糖素、脂联素、HOMA-IR	指标类型：	次要指标
Outcome：	Part B MAD trial: fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, adiponectin, HOMA-IR	Type：	Secondary indicator
测量时间点：	治疗4、8、12周后	测量方法：
Measure time point of outcome：	After 4, 8, and 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：空腹血脂（包括TC、LDL-C、TG、HDL-C）	指标类型：	次要指标
Outcome：	Part B MAD trial: fasting blood lipids (including TC, LDL-C, TG, HDL-C)	Type：	Secondary indicator
测量时间点：	治疗4、8、12周后	测量方法：
Measure time point of outcome：	After 4, 8, and 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：坐位收缩压、舒张压	指标类型：	次要指标
Outcome：	Part B MAD trial: seated systolic blood pressure, diastolic blood pressure	Type：	Secondary indicator
测量时间点：	治疗4、8、12周后	测量方法：
Measure time point of outcome：	After 4, 8, and 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：血尿酸	指标类型：	附加指标
Outcome：	Part B MAD trial: serum uric acid	Type：	Additional indicator
测量时间点：	治疗4、8、12周后	测量方法：
Measure time point of outcome：	After 4, 8, and 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：糖化血红蛋白（HbA1c）	指标类型：	附加指标
Outcome：	Part B MAD trial: glycated hemoglobin (HbA1c)	Type：	Additional indicator
测量时间点：	治疗12周后	测量方法：
Measure time point of outcome：	After 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：MRI-PDFF（仅适用于Fibroscan/Fibrotouch结果提示有脂肪肝者）	指标类型：	附加指标
Outcome：	Part B MAD trial: MRI-PDFF (only applicable to subjects with fatty liver indicated by Fibroscan/Fibrotouch results)	Type：	Additional indicator
测量时间点：	治疗12周后	测量方法：
Measure time point of outcome：	After 12 weeks of treatment	Measure method：

指标中文名：	Part B MAD试验：血药浓度	指标类型：	主要指标
Outcome：	Part B MAD trial: plasma drug concentration	Type：	Primary indicator
测量时间点：	每个计划采血时间点	测量方法：
Measure time point of outcome：	Each planned blood sampling time point	Measure method：

指标中文名：	Part B MAD试验：首次给药后主要PK参数（包括但不限于：Cmax、Tmax、Ctrough和AUC0-t；如数据允许，还将包括AUC0-168h、AUC0-∞、AUC_%Extrap、λz、t1/2、CL/F和Vz/F等）	指标类型：	主要指标
Outcome：	Part B MAD trial: main PK parameters after first dosing (including but not limited to Cmax, Tmax, Ctrough and AUC0-t; if data permit, AUC0-168h, AUC0-∞, AUC_%Extrap, λz, t1/2, CL/F and Vz/F, etc.)	Type：	Primary indicator
测量时间点：	首次给药后	测量方法：
Measure time point of outcome：	After first dosing	Measure method：

指标中文名：	Part B MAD试验：末次给药后主要PK参数（包括但不限于：Cmax、Tmax、Ctrough、Rac_Cmax、Rac_Ctrough、Tlast和AUC0-t；如数据允许，还将计算AUC0-tau即AUC0-168h、AUC0-∞、AUC_%Extrap、λz、t1/2、CL/F、Vz/F和Rac_AUC等）	指标类型：	主要指标
Outcome：	Part B MAD trial: main PK parameters after last dosing (including but not limited to Cmax, Tmax, Ctrough, Rac_Cmax, Rac_Ctrough, Tlast and AUC0-t; if data permit, AUC0-tau, namely AUC0-168h, AUC0-∞, AUC_%Extrap, λz, t1/2, CL/F, Vz/F and Rac_AUC, etc.)	Type：	Primary indicator
测量时间点：	末次给药后	测量方法：
Measure time point of outcome：	After last dosing	Measure method：

指标中文名：	Part B MAD试验：药效学指标（包括体重、腰围、腰臀比；空腹血糖、空腹胰岛素、空腹C肽、空腹胰高血糖素、空腹血脂[包括TC、LDL-C、TG、HDL-C]、脂联素、HOMA-IR；坐位收缩压、舒张压；血尿酸；糖化血红蛋白；MRI-PDFF[仅适用于Fibroscan/Fibrotouch结果提示有脂肪肝者]）	指标类型：	次要指标
Outcome：	Part B MAD trial: pharmacodynamic indicators (including body weight, waist circumference, waist-to-hip ratio; fasting glucose, fasting insulin, fasting C-peptide, fasting glucagon, fasting blood lipids [including TC, LDL-C, TG, HDL-C], adiponectin, HOMA-IR; seated systolic blood pressure, diastolic blood pressure; serum uric acid; glycated hemoglobin; MRI-PDFF [only applicable to subjects with fatty liver indicated by Fibroscan/Fibrotouch results])	Type：	Secondary indicator
测量时间点：	基线及给药后	测量方法：
Measure time point of outcome：	Baseline and after dosing	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	65	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机化专员采用统计软件模拟，按剂量组随机，产生随机编码。申办者生产部门在编盲人员的指导下，按照药品编号进行药品包装，相同剂量组中，试验药和安慰剂的药品标签除药品编号之外，其他信息完全一致。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomization commissioner used statistical software simulation to randomize by dose group and generate random codes. The sponsor's manufacturing department, under the guidance of the blinded personnel, packaged the drug according to the drug number, and the drug labels of the test drug and the placebo in the same dosage group were identical except for the drug number.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	双盲
Blinding：	Double blind

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	研究结束后半年；国家生物信息中心(https://www.cncb.ac.cn/)
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Six months after the completion of the research; China National Center for Bioinformation (https://www.cncb.ac.cn/)
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	本研究的临床试验数据管理的工作由申办者负责，并使用电子数据采集系统（EDC）进行研究数据的收集与管理。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The sponsor was responsible for the management of the clinical trial data for this study and used an electronic data capture (EDC) system for the collection and management of study data.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-05-21 10:10:10