ChiCTR2600118669 版本V1.0 版本创建时间2026/02/09 23:39:40 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600118669 

最近更新日期：

Date of Last Refreshed on：

 2026-02-09 23:34:57 

注册时间：

Date of Registration：

 2026-02-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评估健康受试者和超重/肥胖受试者单次皮下注射UBT37034的安全性、耐受性、药代动力学、药效学和免疫原性的I期临床试验

Public title：

Phase I Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a Single Subcutaneous Injection of UBT37034 in Healthy Subjects and Overweight/Obsese Subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估健康受试者和超重/肥胖受试者单次皮下注射UBT37034的安全性、耐受性、药代动力学、药效学和免疫原性的I期临床试验

Scientific title：

Phase I Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of a Single Subcutaneous Injection of UBT37034 in Healthy Subjects and Overweight/Obsese Subjects

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：

黄洁 

研究负责人：

阳国平 

Applicant：

Huang Jie 

Study leader：

Yang Guoping 

申请注册联系人电话：

Applicant telephone：

 +86 731 8991 8665

研究负责人电话：

Study leader's
telephone：

+86 731 8991 8938

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：

 cellahuang1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@126.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：

中国湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, China

Study leader's address：

No. 138 Tongzipo Road, Yuelu District, Changsha City, Hunan Province, 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：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验研究中心

Affiliation of the Leader：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South 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：

 25231

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Third Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-18 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Wang Xiaomin

伦理委员会联系地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Contact Address of the ethic committee：

No. 138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 8861 8938

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中南大学湘雅三医院

Primary sponsor：

The Third Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

No. 138 Tongzipo Road, Yuelu District, Changsha, Hunan, 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)：

湖南

市(区县)：

Country：

China

Province：

Human

City：

单位(医院)：

中南大学湘雅三医院

具体地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Institution
hospital：

Xiangya Third Hospital of Central South University

Address：

No. 138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

经费或物资来源：

联邦生物科技（珠海横琴）有限公司

Source(s) of funding：

Federal Biotechnology (Zhuhai Hengqin) Co., Ltd

研究疾病：

超重/肥胖  

Target disease：

Overweight/Obsesity

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：

评价健康受试者和超重/肥胖受试者单次皮下注射UBT37034的安全性和耐受性（包含局部耐受性）。 评价健康受试者和超重/肥胖受试者单次皮下注射UBT37034的药代动力学（PK）和药效学（PD）特征； 评价健康受试者和超重/肥胖受试者单次皮下注射UBT37034的免疫原性特征。  

Objectives of Study：

Evaluate the safety and tolerability (including local tolerability) of a single subcutaneous injection of UBT37034 in healthy and overweight/obese subjects. Evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single subcutaneous injection of UBT37034 in healthy and overweight/obese subjects; Evaluate the immunogenicity characteristics of a single subcutaneous injection of UBT37034 in healthy and overweight/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：

1、 签署知情同意书时，年龄18~55周岁（含临界值），男女不限； 2、 筛选期体重男性＞60kg，女性＞50 kg。健康受试者19kg/m^2＜＝BMI＜24kg/m^2，超重/肥胖受试者24kg/m^2＜＝BMI＜＝35kg/m^2； 3、 随机分组前 3 个月内体重保持稳定（体重变化＜5%）； 4、 在随机分组前 3 个月内未调整饮食或采取任何改变营养生活方式的措施； 5、 受试者愿意自签署知情同意书至试验用药品给药后3个月自愿采取适当有效避孕措施（具体见附录3），试验用药品给药后3个月内无捐献精子、卵子计划； 6、 受试者能够和研究者进行良好的沟通，对本研究已充分了解，自愿参加，并且理解和遵守本研究的各项要求，签署书面的知情同意书。

Inclusion criteria

1. When signing the informed consent form, the age range is between 18 and 55 years old (including the threshold), regardless of gender; 2. During the screening period, the weight of males was greater than 60kg and females was greater than 50kg. Healthy subjects had a BMI of 19kg/m ^ 2<=24kg/m ^ 2, while overweight/obese subjects had a BMI of 24kg/m ^ 2<=35kg/m ^ 2; 3. Maintain stable weight within the first 3 months of randomization (weight change<5%); 4. Not adjusting diet or taking any measures to change nutritional lifestyle within 3 months prior to randomization; 5. The subjects are willing to voluntarily take appropriate and effective contraceptive measures from the time of signing the informed consent form until 3 months after the administration of the investigational drug (see Appendix 3 for details). There is no plan to donate sperm or eggs within 3 months after the administration of the investigational drug; 6. The subjects are able to communicate well with the researchers, have a full understanding of the study, voluntarily participate, and understand and comply with the requirements of the study, signing a written informed consent form.

排除标准：

1、 已知对试验药物或其制剂辅料过敏，或对神经肽Y受体激动剂类药物或生物制剂过敏者，或现症过敏疾病患者或高敏体质者； 2、 筛选前3个月内使用过影响体重的药物，包括但不限于：1）神经肽Y受体激动剂作用机制相似的减重或降糖药物；2）已上市或试验性减重药（如GLP1类似物、 奥利司他等）；3）三环类抗抑郁药、精神类药物或镇静药（如米氮平、帕罗西汀、 奥氮平、丙戊酸及其衍生物等）；4）全身用糖皮质激素（静脉/口服/关节腔注射）; 3、 给药前14天内用过任何非处方药、处方药、中草药和/或营养剂，或研究期间计划使用下列药物：1）减低胃肠道蠕动能力的药物，包括但不限于抗胆碱药、抗痉挛药、5-羟色胺-3受体拮抗剂、多巴胺拮抗剂和阿片类药物；2）已知可延长QT/QTc间期的药物；3）筛选前1个月内接种过疫苗或计划在试验期间接种疫苗者；4） 其他可能对试验评价产生影响的药物； 4、有以下任何一种疾病的病史或证据者：a) 诊断为1型或2型糖尿病，或妊娠糖尿病或其他类型糖尿病；b)入组前12个月内发生过需医疗干预的有症状的低血糖，或近6个月内反复发作有症状低血糖（≥2次）；c) 合并有胃轻瘫或其他胃肠排空障碍相关疾病（如幽门梗阻、肠梗阻等）未控制的胃食管反流病、研究者评估为增加用药后风险的胃肠道疾病（如严重的活动性溃疡、炎症性肠病、胃食管反流病、急性胃肠炎、症状性慢性胃肠 炎、功能性胃肠病、肠结核等）；d) 有慢性心/肾/肝病史（健康受试者轻度脂肪肝除外，超重/肥胖受试者轻、中度脂肪肝除外），或近5年内有恶性肿瘤史（充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的乳腺导管原位癌除外）者；e) 既往有抑郁症病史或有严重精神疾病史，包括但不限于自杀倾向或自杀未遂、精神分裂症、双向情感障碍症等；f) 筛选时患者健康问卷（PHQ-9）评分≥5分；g) 既往有临床严重的或目前在临床上有明显或有临床意义的疾病/异常（包括但不限于神经系统、心血管系统、呼吸系统、血液和淋巴系统、免疫系统、肾脏、肝脏、胃肠道、代谢及骨骼等系统疾病、神经病学或精神病学疾病/异常）者； 5、 筛选时有符合下列标准的任何检查异常者：a) HbA1c＞＝6.5%，或健康受试者空腹血糖＞＝6.1 mmol/L 者，超重/肥胖受试者空腹血糖＞＝7.0 mmol/L 者 ；b) 肝、肾功能损害，根据各医院实验室的参考值指标，血清 ALT、AST 超过参考值范围上限2倍，血清总胆红素超过参考值范围上限的1.5倍（如果 ALT、AST 接近参考值范围上限 2 倍但未超过，同时总胆红素接近1.5倍上限但未超过，需由研究者综合评估是否可纳入）；肾小球滤过率估测值（eGFR）＜60ml·min-1·1.73m-2（根据 CKD-EPI 公式计算，详见附录 1）；c) 健康受试者空腹甘油三脂异常有临床意义者，超重/肥胖受试者空腹甘油三酯＞＝5.0 mmol/L；d) 国际标准化比值（INR）大于正常范围上限；e) 严重的心电图异常，定义为a）二度或三度房室传导阻滞；b）长 QT 综合征或 QTcF（Fridericia 公式校正）男性＞＝450 ms，女性＞＝460 ms；c）左右束支阻滞；d）预激综合征，或 e）需要治疗的严重心律失常；f）心率＜50 次/min或＞100 次/min；f) 体格检查、生命体征、实验室检查等显示异常有临床意义，且经研究者判断可能对受试者构成重大风险或干扰对安全性、PK 或 PD 结果评价而不适宜参加该试验者； 6、 筛选时乙型肝炎表面抗原检查阳性、丙型肝炎病毒抗体检查阳性、人免疫缺陷病毒抗体检查阳性或梅毒抗体检查阳性者； 7、 筛选前接受过任何减肥手术者或筛选前6个月内接受过任何对试验评估产生影响的手术者； 8、 筛选前3个月内失血或献血超过400mL，或接受过血液或血液成份输注者；或并发血红蛋白病、溶血性贫血、镰状细胞性贫血或血红蛋白<110g/L（男性）或<100g/L（女性）； 9、 筛选前3个月内参加过任何药物或医疗器械的临床试验，参加临床试验定义为：签署知情同意，并使用过试验用药品（含安慰剂）或试验医疗器械；或仍在试验药物7个半衰期内（以较长者为准）； 10、 既往有药物滥用史，或尿药筛查阳性者； 11、 给药前3个月内每日吸烟超过5支香烟或等量烟草的或者试验期间不能戒烟者； 12、给药前28天内女性每周饮酒超过7杯或男性每周饮酒超过14杯（1杯=150mL（5盎司）葡萄酒=360mL（12盎司）啤酒=45mL（1.5盎司）烈酒），或给药前48小时内服用过任何含酒精的制品，或基线访视时酒精呼气试验为阳性者，或试验期间不能禁酒者； 13、 给药前14天内饮用过量（一天8杯以上，1 杯=200mL）茶、咖啡或含咖啡因的饮料，或食用葡萄柚（西柚）、或富含黄嘌呤的食物或饮料者，或单次给药前48小时内及试验期间不能停止食用富含黄嘌呤成分的食物或饮料（如巧克力、茶、 咖啡及可乐等）、或葡萄柚（西柚）或柚子以及含葡萄柚或柚子成分的产品（西柚汁、柚子汁等）者； 14、 哺乳期女性或妊娠期女性； 15、 不能耐受静脉穿刺者，有晕针或晕血史者； 16、 试验期间不能保持规律饮食和运动，研究者认为不适合参加临床试验或其他无法参加临床试验的情况等。

Exclusion criteria：

1. Known to be allergic to the experimental drug or its excipients, or to neuropeptide Y receptor agonists or biologics, or to patients with current allergic diseases or high sensitivity constitution; 2. Screening for drugs that affect weight within the previous 3 months, including but not limited to: 1) weight loss or hypoglycemic drugs with similar mechanisms of action as neuropeptide Y receptor agonists; 2) Marketed or experimental weight loss drugs (such as GLP1 analogs, orlistat, etc.); 3) Tricyclic antidepressants, psychotropic drugs or sedatives (such as olanzapine, paroxetine, olanzapine, valproic acid and its derivatives, etc.); 4) Whole body administration of glucocorticoids (intravenous/oral/intra-articular injection); 3. Have used any over-the-counter drugs, prescription drugs, herbal medicines, and/or nutritional supplements within 14 days prior to administration, or plan to use the following drugs during the study period: 1) drugs that reduce gastrointestinal motility, including but not limited to anticholinergic drugs, antispasmodic drugs, serotonin receptor antagonists, dopamine antagonists, and opioid drugs; 2) Drugs known to prolong the QT/QTc interval; 3) Screening individuals who have received vaccines within the previous month or plan to receive vaccines during the trial period; 4) Other drugs that may affect the evaluation of the experiment; 4. Those who have any medical history or evidence of any of the following diseases: a) diagnosed as type 1 or type 2 diabetes, or pregnancy diabetes or other types of diabetes; b) Symptomatic hypoglycemia requiring medical intervention occurred within the 12 months prior to enrollment, or recurrent symptomatic hypoglycemia occurred within the past 6 months (≥ 2 times); c) Combining uncontrolled gastroesophageal reflux disease with gastric paresis or other gastrointestinal emptying disorders (such as pyloric obstruction, intestinal obstruction, etc.), and gastrointestinal diseases assessed by researchers as increasing the risk after medication (such as severe active ulcers, inflammatory bowel disease, gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastrointestinal disease, intestinal tuberculosis, etc.); d) Individuals with a history of chronic heart/kidney/liver disease (excluding mild fatty liver in healthy subjects and mild to moderate fatty liver in overweight/obese subjects), or a history of malignant tumors within the past 5 years (excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery); e) History of depression or severe mental illness, including but not limited to suicidal tendencies or attempted suicide, schizophrenia, bipolar disorder, etc; f) Patient Health Questionnaire (PHQ-9) score ≥ 5 during screening; g) Individuals who have previously had clinically severe or currently have significant or clinically meaningful diseases/abnormalities (including but not limited to neurological, cardiovascular, respiratory, blood and lymphatic, immune, kidney, liver, gastrointestinal, metabolic, and skeletal system diseases, neurological or psychiatric diseases/abnormalities); 5. During screening, there are any abnormal individuals who meet the following criteria: a) HbA1c>=6.5%, or fasting blood glucose>=6.1 mmol/L in healthy subjects, or fasting blood glucose>=7.0 mmol/L in overweight/obese subjects; b) Liver and kidney function impairment, according to the reference value indicators of various hospital laboratories, serum ALT and AST exceed the upper limit of the reference value range by 2 times, and serum total bilirubin exceeds the upper limit of the reference value range by 1.5 times (if ALT and AST are close to the upper limit of the reference value range but not exceeding, and total bilirubin is close to the upper limit of 1.5 times but not exceeding, the researcher needs to comprehensively evaluate whether they can be included); The estimated glomerular filtration rate (eGFR) is less than 60ml · min-1 · 1.73m-2 (calculated according to the CKD-EPI formula, see Appendix 1 for details); c) Healthy subjects with abnormal fasting triglycerides have clinical significance, while overweight/obese subjects have fasting triglycerides>=5.0 mmol/L; d) The International Normalized Ratio (INR) is greater than the upper limit of the normal range; e) Severe electrocardiographic abnormalities, defined as a) second or third degree atrioventricular block; b) Long QT syndrome or QTcF (Fridericia formula corrected)>=450 ms for males and>=460 ms for females; c) Left and right bundle branch block; d) Pre excitation syndrome, or e) severe arrhythmia requiring treatment; f) Heart rate<50 beats/min or>100 beats/min; f) Individuals who show abnormalities in physical examination, vital signs, laboratory tests, etc. that have clinical significance and may pose significant risks to the subjects or interfere with the evaluation of safety, PK, or PD results, as determined by the researchers, are not suitable to participate in the trial; 6. Individuals who test positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis antibody during screening; 7. Individuals who have undergone any weight loss surgery prior to screening or those who have undergone any surgery that affects the evaluation of the trial within the 6 months prior to screening; 8. Screening for individuals who have lost blood or donated more than 400mL of blood within the previous 3 months, or have received blood or blood component infusions; Or concurrent hemoglobinopathy, hemolytic anemia, sickle cell anemia, or hemoglobin<110g/L (male) or<100g/L (female); 9. Participate in any clinical trials of drugs or medical devices within the first 3 months of screening. Participation in clinical trials is defined as: signing informed consent and using the investigational drug (including placebo) or investigational medical device; Or still within 7 half lives of the investigational drug (whichever is longer); 10. Individuals with a history of drug abuse or positive urine drug screening; 11. Individuals who smoke more than 5 cigarettes or an equivalent amount of tobacco per day within the 3 months prior to administration, or who are unable to quit smoking during the trial period; 12. Women who consume more than 7 glasses of alcohol per week or men who consume more than 14 glasses of alcohol per week (1 glass=150mL (5 ounces) of wine=360mL (12 ounces) of beer=45mL (1.5 ounces) of liquor) within 28 days prior to administration, or who have taken any alcoholic products within 48 hours prior to administration, or who tested positive for alcohol breath test at baseline visit, or who cannot abstain from alcohol during the trial period; 13. Those who consume excessive amounts (8 or more cups per day, 1 cup=200mL) of tea, coffee, or caffeinated beverages, or consume grapefruit (grapefruit), or foods or beverages rich in xanthine within 14 days before administration, or who cannot stop consuming foods or beverages rich in xanthine (such as chocolate, tea, coffee, cola, etc.), or grapefruit (grapefruit) or grapefruit, as well as products containing grapefruit or grapefruit (grapefruit juice, grapefruit juice, etc.) within 48 hours before a single administration and during the trial period; 14. Lactating or pregnant women; 15. Individuals who cannot tolerate venipuncture and have a history of needle or blood dizziness; 16. During the trial period, it was not possible to maintain a regular diet and exercise, and the researchers deemed it unsuitable to participate in clinical trials or other situations that prevented participation.

研究实施时间：

Study execute time：

从 From 2025-12-12 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-09 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：

第1组

样本量：

 2

Group：

Group 1

Sample size：

干预措施：

注射用UBT37034 2例；空腹状态下（给药前禁食至少10h，饮水除外），卧位状态下，皮下注射 UBT37034 0.05mg，腹部脐周约5cm外皮下注射并停留至少10秒，同时检查注射情况（如是否漏液等）及注射部位反应（给药后5min内）。给药后继续禁食4h。

干预措施代码：

Intervention：

UBT37034 for injection: 2 cases; under fasting condition (fasting for at least 10 h before administration, except for water intake) and in the supine position, UBT37034 0.05 mg was administered via subcutaneous injection at the abdomen, approximately 5 cm away from the umbilicus, with the needle retained for at least 10 seconds. Meanwhile, the injection status (e.g., extravasation) and local reactions at the injection site were examined within 5 min after administration. Fasting was continued for 4 h post-administration.

Intervention code：

组别：

第2组

样本量：

 10

Group：

Group 2

Sample size：

干预措施：

注射用UBT37034 8例/安慰剂2例；空腹状态下（给药前禁食至少10h，饮水除外），卧位状态下，皮下注射 UBT37034 0.2mg或安慰剂，腹部脐周约5cm外皮下注射并停留至少10秒，同时检查注射情况（如是否漏液等）及注射部位反应（给药后5min内）。给药后继续禁食4h。

干预措施代码：

Intervention：

UBT37034 for injection: 8 cases / placebo: 2 cases; under fasting conditions (fasting for at least 10 h before administration, water intake permitted), subjects were placed in the supine position for subcutaneous injection of UBT37034 0.2 mg or placebo at the abdominal area approximately 5 cm from the umbilicus, with the needle held in place for at least 10 seconds. Injection status (e.g., extravasation) and local reactions at the injection site were assessed within 5 minutes post-administration. Fasting was maintained for an additional 4 hours after drug administration.

Intervention code：

组别：

第3组

样本量：

 10

Group：

Group 3

Sample size：

干预措施：

注射用UBT37034 8例/安慰剂2例；空腹状态下（给药前禁食至少10h，饮水除外），卧位状态下，皮下注射 UBT37034 0.5mg，腹部脐周约5cm外皮下注射并停留至少10秒，同时检查注射情况（如是否漏液等）及注射部位反应（给药后5min内）。给药后继续禁食4h。

干预措施代码：

Intervention：

UBT37034 for injection: 8 cases / placebo: 2 cases; under fasting conditions (fasting for at least 10 h before administration, water intake permitted), subjects were placed in the supine position for subcutaneous injection of UBT37034 0.5 mg or placebo at the abdominal area approximately 5 cm from the umbilicus, with the needle held in place for at least 10 seconds. Injection status (e.g., extravasation) and local reactions at the injection site were assessed within 5 minutes post-administration. Fasting was maintained for an additional 4 hours after drug administration.

Intervention code：

组别：

第4组

样本量：

 10

Group：

Group 4

Sample size：

干预措施：

注射用UBT37034 8例/安慰剂2例；空腹状态下（给药前禁食至少10h，饮水除外），卧位状态下，皮下注射 UBT37034 1.0mg，腹部脐周约5cm外皮下注射并停留至少10秒，同时检查注射情况（如是否漏液等）及注射部位反应（给药后5min内）。给药后继续禁食4h。

干预措施代码：

Intervention：

UBT37034 for injection: 8 cases / placebo: 2 cases; under fasting conditions (fasting for at least 10 h before administration, water intake permitted), subjects were placed in the supine position for subcutaneous injection of UBT37034 1.0mg or placebo at the abdominal area approximately 5 cm from the umbilicus, with the needle held in place for at least 10 seconds. Injection status (e.g., extravasation) and local reactions at the injection site were assessed within 5 minutes post-administration. Fasting was maintained for an additional 4 hours after drug administration.

Intervention code：

组别：

第5组

样本量：

 10

Group：

Group 5

Sample size：

干预措施：

注射用UBT37034 8例/安慰剂2例；空腹状态下（给药前禁食至少10h，饮水除外），卧位状态下，皮下注射 UBT37034 2.0mg，腹部脐周约5cm外皮下注射并停留至少10秒，同时检查注射情况（如是否漏液等）及注射部位反应（给药后5min内）。给药后继续禁食4h。

干预措施代码：

Intervention：

UBT37034 for injection: 8 cases / placebo: 2 cases; under fasting conditions (fasting for at least 10 h before administration, water intake permitted), subjects were placed in the supine position for subcutaneous injection of UBT37034 2.0 mg or placebo at the abdominal area approximately 5 cm from the umbilicus, with the needle held in place for at least 10 seconds. Injection status (e.g., extravasation) and local reactions at the injection site were assessed within 5 minutes post-administration. Fasting was maintained for an additional 4 hours after drug administration.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

 长沙 

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

 中南大学湘雅三医院临床试验研究中心 

单位级别：

 三级甲等 

Institution
hospital：

Clinical Trial Research Center of Xiangya Third Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

不良事件发生率

指标类型：

主要指标

Outcome：

Incidence of Adverse Events

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

峰浓度（Cmax）

指标类型：

次要指标

Outcome：

Maximum Plasma Concentration (Cmax)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达峰时间（Tmax）

指标类型：

次要指标

Outcome：

Time to Maximum Plasma Concentration (Tmax)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药-时曲线下面积（AUC0-t, AUC0-∞）

指标类型：

次要指标

Outcome：

Area Under the Curve (AUC0-t, AUC0-∞)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

消除半衰期（t1/2z）

指标类型：

次要指标

Outcome：

Elimination Half-life (t1/2z)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

表观分布容积（Vz/F）和表观清除率（CL/F）

指标类型：

次要指标

Outcome：

Apparent Volume of Distribution (Vz/F) and Apparent Clearance (CL/F)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体重、腰围、臀围、腰臀比的变化

指标类型：

次要指标

Outcome：

Changes in Body Weight, Waist Circumference, Hip Circumference, and Waist-to-Hip Ratio

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

空腹血糖和空腹血脂的变化

指标类型：

次要指标

Outcome：

Changes in Fasting Blood Glucose and Fasting Lipid Levels

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

食欲视觉模拟量表（VAS）评分的变化

指标类型：

次要指标

Outcome：

Change in Appetite Visual Analog Scale (VAS) Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

食物摄入量的变化

指标类型：

次要指标

Outcome：

Change in Food Intake

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

对QT/QTc间期的影响

指标类型：

次要指标

Outcome：

Effect on QT/QTc Interval

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抗UBT37034抗体的阳性率和滴度水平

指标类型：

次要指标

Outcome：

Seropositivity Rate and Titer Level of Anti-UBT37034 Antibodies

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抗UBT37034中和抗体阳性率

指标类型：

次要指标

Outcome：

Seropositivity Rate of Anti-UBT37034 Neutralizing Antibodies

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

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

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

粪便

组织：

Sample Name：

Feces

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 55 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）：

由统计单位随机人员以SAS软件（9.4或以上版本）产生随机号及对应治疗组别。按是否超重/肥胖（19 kg/m^2 <= BMI < 24 kg/m^2为健康受试者，24 kg/m^2 <= BMI <= 35 kg/m^2为超重或肥胖受试者）进行分层随机。每个剂量组内健康受试者与超重/肥胖受试者按1:1比例入组，第2~5组中安慰剂组各分配1名健康受试者和1名超重/肥胖受试者。

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

Randomization numbers and corresponding treatment groups will be generated by statistical staff using SAS software (version 9.4 or higher). Stratified randomization will be performed based on weight status (healthy subjects: 19 kg/m^2 <= BMI < 24 kg/m^2; overweight or obese subjects: 24 kg/m^2 <= BMI <= 35 kg/m^2). Within each dose group, healthy and overweight/obese subjects will be enrolled in a 1:1 ratio. In groups 2 through 5, the placebo arm will include one healthy subject and one overweight/obese subject each.

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：

除哨兵组（第1组）为开放设计外，其余剂量组均采用双盲设计。试验药与安慰剂在外观、气味、包装上保持一致，每例受试者使用相同批号药品。药物现场编盲由随机人员与无关第三方共同完成，编盲人员不参与后续试验工作。PK生物分析单位在检测前需申请盲底，仅对试验药组样本进行检测（特殊情况下除外）。非盲态人员（如PK分析负责人、安全评估人员）需签署保密声明，不得泄露盲底信息，直至数据库锁库。

Blinding：

Except for the sentinel group (Group 1) which was an open design, all other dose groups adopted a double-blind design. The test drug and the placebo were consistent in appearance, smell and packaging, and each subject used the same batch number of the drug. On-site drug blinding was jointly completed by random personnel and unrelated third parties, and the blinding personnel did not participate in the subsequent trial work. PK biological analysis units need to apply for a blind background before testing and only conduct tests on the samples of the test drug group (except in special circumstances). Non-blind personnel (such as PK analysis managers and security assessors) must sign a confidentiality statement and must not disclose blind background information until the database is locked.

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）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

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：

数据采集：由研究者或其授权的CRC通过独立的账号进入数据管理系统，进行数据采集。 数据管理：数据管理员根据方案设计eCRF，eCRF中包含除外部数据外方案中规定的全部数据点。由EDC系统直接导出eCRF（PDF格式）。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection: Researchers or their authorized clinical research coordinators (CRCs) access the data management system through independent accounts to conduct data collection. Data management: Data managers design the electronic case report forms (eCRF) according to the protocol. The eCRF contains all the data points specified in the protocol except for external data. The eCRF (in PDF format) is directly exported from the Electronic Data Capture (EDC) system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-02-09 23:34:57