ChiCTR2500100057 版本V1.0 版本创建时间2025/04/02 10:23:41 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：

 ChiCTR2500100057 

最近更新日期：

Date of Last Refreshed on：

 2025-04-02 10:23:27 

注册时间：

Date of Registration：

 2025-04-02 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

评价CMS-D001在健康受试者安全性、耐受性和药代动力学的随机、双盲、安慰剂对照、单次或多次给药剂量递增及食物影响（开放）的I期临床研究

Public title：

A randomized, double-blind, placebo-controlled, single or multiple dose escalation and food effect (open) Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of CMS-D001 in healthy subjects

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价CMS-D001在健康受试者安全性、耐受性和药代动力学的随机、双盲、安慰剂对照、单次或多次给药剂量递增及食物影响（开放）的I期临床研究

Scientific title：

A randomized, double-blind, placebo-controlled, single or multiple dose escalation and food effect (open) Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of CMS-D001 in healthy 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：

隋芳慧 

研究负责人：

黄朝林 

Applicant：

Fanghui Sui 

Study leader：

Zhaolin Huang 

申请注册联系人电话：

Applicant telephone：

 +86 182 0088 5182

研究负责人电话：

Study leader's
telephone：

+86 153 0717 3189

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：

 suifanghui@cms.net.cn

研究负责人电子邮件：

Study leader's E-mail：

 88071718@qq.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：

深圳市南山区南头街道马家龙社区南山大道3186号莲花广场B栋801

研究负责人通讯地址：

武汉市东西湖区银潭路1号

Applicant address：

801, Building B, Lotus Plaza, No. 3186, Nanshan Avenue, Majialong Community, Nantou Street, Nanshan District, Shenzhen

Study leader's address：

No. 1, Yintan Road, Dongxihu District, Wuhan City

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：

海南康哲美丽科技有限公司

Applicant's institution：

Hainan Kangzhe Beauty Technology Co., Ltd.

研究负责人所在单位：

武汉市金银潭医院(武汉市传染病医院)

Affiliation of the Leader：

Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)

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：

 GCP-ICT-2024-19

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：

武汉市传染病医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Wuhan Infectious Disease Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-06-26 00:00:00

伦理委员会联系人：

葛老师

Contact Name of the ethic committee：

Teacher Ge

伦理委员会联系地址：

武汉市东西湖区银潭路1号

Contact Address of the ethic committee：

No. 1 Yintan Road, Dongxihu District, Wuhan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 8550 9839

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：

武汉市金银潭医院（武汉市传染病医院）

Primary sponsor：

Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)

研究实施负责（组长）单位地址：

武汉市东西湖区银潭路1号

Primary sponsor's address：

No. 1 Yintan Road, Dongxihu District, Wuhan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

海南省

市(区县)：

Country：

China

Province：

Hainan

City：

单位(医院)：

海南康哲美丽科技有限公司

具体地址：

海南省海口市国家高新技术产业开发区科技大道22号海口国科中心C座6楼整层

Institution
hospital：

Hainan Kangzhe Beauty Technology Co., Ltd.

Address：

6th Floor, Block C, Haikou National Science and Technology Center, No. 22 Science and Technology Avenue, National High tech Industrial Development Zone, Haikou City, Hainan Province

经费或物资来源：

海南康哲美丽科技有限公司

Source(s) of funding：

Hainan Kangzhe Beauty Technology Co., Ltd.

研究疾病：

银屑病  

Target disease：

Psoriasis vulgaris

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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

Part-1 SAD & Part-2 MAD 主要目的:评价单次或多次口服CMS-D001的安全性和耐受性 次要目的:评价单次或多次口服CMS-D001的药代动力学(PK)特征;评价单次或多次口服CMS-D001的药效动力学(PD)特征 其他目的:考察血浆中的代谢产物/特征;评价口服CMS-D001对心脏QT间期的影响 Part-3:FE(食物影响)研究 主要目的:评价食物对单次口服CMS-D001暴露量的影响 次要目的:评价空腹或餐后条件下单次口服CMS-D001的安全性和耐受性  

Objectives of Study：

Part-1 SAD & Part-2 MAD Main objective: To evaluate the safety and tolerability of single or multiple oral administration of CMS-D001 Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of single or multiple oral doses of CMS-D001;To evaluate the pharmacodynamic (PD) characteristics of single or multiple oral doses of CMS-D001 Other purposes: Investigating metabolites/characteristics in plasma; Evaluating the effect of oral CMS-D001 on cardiac QT interval Part-3: FE (Food Effects) Study Main objective: To evaluate the effect of food on single oral exposure to CMS-D001 Secondary objective: To evaluate the safety and tolerability of single oral administration of CMS-D001 under fasting or postprandial conditions

药物成份或治疗方案详述：

本研究是一项在中国成年健康受试者中开展的随机、双盲或开放标签（仅FE研究）研究，包含3个部分。其中，Part-1 SAD和Part-2 MAD旨在评价单次和多次服用CMS-D001时在中国健康成年受试者中的安全性（包括对QT间期影响的评估）、耐受性和PK、PD特征；Part-3食物影响研究（FE）以健康受试者为研究对象，评价食物对CMS-D001全身PK参数的影响。 Part-1 SAD和Part-2 MAD为随机、双盲、安慰剂对照、序贯队列研究，Part-3 FE为随机、开放、两周期、交叉设计研究。所有研究药物包括安慰剂均为口服给药。预计本研究总样本量至少为80例。其中，在Part-1 SAD和Part-2 MAD，各剂量组接受CMS-D001与安慰剂给药的受试者分别为6例和2例，SAD起始剂量（2.5 mg）组例外，分别为3例和1例。Part-1 SAD 6组共44例；Part-2 MAD计划3组，共24例。Part-3 FE研究可评估人数为12例。 

Description for medicine or protocol of treatment in detail：

This study is a randomized, double-blind, or open label (FE study only) study conducted among adult healthy participants in China, consisting of three parts. Among them, Part-1 SAD and Part-2 MAD aim to evaluate the safety (including assessment of QT interval effects), tolerability, PK, and PD characteristics of single and multiple doses of CMS-D001 in healthy adult subjects in China; Part 3 Food Effects Study (FE) focuses on healthy subjects to evaluate the impact of food on the systemic PK parameters of CMS-D001. Part-1 SAD and Part-2 MAD are randomized, double-blind, placebo-controlled, sequential cohort studies, while Part-3 FE is a randomized, open label, two period, crossover design study. All study drugs, including placebo, were administered orally. It is expected that the total sample size of this study will be at least 80 cases. Among them, in Part-1 SAD and Part-2 MAD, there were 6 and 2 subjects in each dose group who received CMS-D001 and placebo, respectively. The SAD starting dose (2.5 mg) group was an exception, with 3 and 1 subjects, respectively. Part 1 SAD 6 group, a total of 44 cases; Part 2 MAD program consists of 3 groups, with a total of 24 cases. The number of evaluatable individuals for the Part-3 FE study is 12. 

纳入标准：

1.自愿参加本研究，并签署知情同意书，能够和研究者进行良好的沟通，并且理解和遵守本研究的各项要求和限制条件； 2.年龄18 - 55周岁（含边界值，以签署知情同意书当天为准），男性和女性； 3.筛选时体重指数（BMI）在18.0 - 28.0 kg/m^2范围内（含边界值），且男性体重>= 50 kg，女性体重>=45 kg； 4.筛选时无活动性或潜伏性或既往结核杆菌（TB）感染证据，γ-干扰素释放试验（IGRA）和胸部X光片（正位）检查为阴性； 5.体格检查、生命体征检查[参考值范围（包括边界值）：收缩压140 - 90 mmHg，舒张压60 - 90 mmHg，脉搏50 - 100 bpm，体温（耳温）35.8-37.2℃]、实验室检查、12-导联心5)电图及其他辅助检查结果正常或经研究者判断异常无临床意义； 6.有生育能力的志愿者自签署知情同意书之日开始至研究药物末次用药后3个月期间无怀孕或捐精计划，且此期间必须遵守避孕的相关规定（见附录1），必须同意采取至少一种高效的非激素避孕方法，或男性伴侣已在筛选访视前至少6个月行绝育手术等。

Inclusion criteria

1. Voluntarily participate in this study, sign the informed consent form, be able to communicate well with the researcher, and understand and comply with the requirements and restrictions of this study; 2. Age 18 - 55 years old (including the boundary value, subject to the day of signing the informed consent), male and female; 3. Body mass index (BMI) within the range of 18.0 - 28.0 kg/m^2 (including boundary value) at screening, and weight > = 50 kg for males and > for females=45 kg; 4. No active or latent or previous evidence of Mycobacterium tuberculosis (TB) infection at screening, negative γ-interferon release test (IGRA) and chest X-ray (anteroposterior); 5. Physical examination, vital signs examination [reference value range (including boundary value): systolic blood pressure 140 - 90 mmHg, diastolic blood pressure 60 - 90 mmHg, pulse 50 - 100 bpm, body temperature (ear temperature) 35.8-37.2 °C], laboratory examination, 12-lead heart 5) electrogram and other auxiliary examination results are normal or judged by the investigator to be abnormal and not clinically significant; 6. Volunteers of childbearing potential have no pregnancy or sperm donation plan from the date of signing the informed consent form to 3 months after the last dose of study drug, and must comply with the relevant regulations of contraception during this period (see Appendix 1), must agree to take at least one highly effective non-hormonal contraceptive method, or the male partner has been sterilized at least 6 months before the screening visit, etc.

排除标准：

过敏史 1.对本研究药物活性成分或其辅料过敏或使用禁忌者； 2.有明显的多发性和/或严重过敏病史，包括食物过敏（注：患季节性过敏症者可能允许参加，有持续症状者除外）。 病史/医疗状况 3.筛选访视前2年内有抑郁症或创伤后应激障碍病史；或有过自杀行为或自杀倾向；或经研究者判断具有自杀倾向（需要时可请精神科医生进行评估），可能会增加参与研究的风险，根据研究者的判断不适合参与研究； 4.筛选前6个月内患严重感染性疾病（如需住院治疗或肠外抗生素治疗或机会性感染），或有慢性或复发性感染性疾病病史； 5.筛选前3个月内，患有症状的带状疱疹或单纯性疱疹； 6.筛选前3个月内有外伤或外科大手术，或接受了可能显著影响安全性评价的手术，或计划在研究过程中接受腹部手术； 7.筛选前7天内有感染和/或发热病史； 8.既往有过淋巴组织增生性疾病； 9.一级亲属患有遗传性免疫缺陷病； 10.既往有过静脉血栓栓塞（VTE）病史或凝血功能障碍； 11.有其他重大代谢、感染或心血管、胃肠道、肝、肾/泌尿、呼吸、内分泌、血液学、免疫、神经系统、生殖系统、皮肤、恶性肿瘤（已切除的且无复发证据的皮肤基底细胞癌和原位宫颈癌除外）或精神疾病的病史或当前状况，需要药物和/或其他治疗，包括饮食限制和物理治疗，研究者认为不适合参加本研究； 12.既往有任何可能影响药物吸收的情况（如胃束带/胃切除术、胆囊切除术、肠切除术）和/或十二指肠疾病（即乳糜泻）（阑尾切除术除外）； 13.既往或或当前存在以下心脏风险因素： a.尖端扭转型室性心动过速或其危险因素，包括使用具有使心脏复极化延迟的药物，低钾血症、低镁血症，以及心力衰竭、心动过缓、心肌病、长QT综合征病史 b.静息至少10分钟，仰卧位测量12-导联心电图，得出的校正QTcF间期> 450 msec[按Fridericia’s公式校正，QTcF=QT(RR.-1/3] c.体位性低血压、不明原因晕厥、心肌梗死、心绞痛、肺充血，以及QT间期延长或传导异常、病态窦房结综合征和II度或III度房室传导阻滞等心律失常，阿-斯综合征或Brugada综合征家族史或个人史 既往/合并治疗 14.在研究给药前6周内接受疫苗接种，或计划在治疗期间的任何时间或研究完成后8周内接种疫苗，或，研究给药结束后2个月内将会和接种了活病毒或减毒活病毒疫苗的人频繁接触； 15.基线前1个月内使用过已知为CYP3A诱导剂或抑制剂的药物或物质（见附录2）； 16.研究给药（Day 1）前14天或至少5个半衰期内使用过任何处方药或非处方药（包括中草药、维生素、矿物质和膳食补充剂等），以较长时间为准； 17.既往使用TYK2抑制剂治疗无效； 18.可能需要在研究期间接受本研究规定的禁用药物或治疗； 药物滥用、酒精、烟草或尼古丁，饮食限制 19.筛选前6个月内和/或筛选期有药物滥用史，或筛选期、基线时尿药检查呈阳性； 20.筛选前6个月内和/或筛选期有酗酒史（酗酒指每日平均饮酒> 2单位酒精[1单位=啤酒240 mL或酒精量为40%的白酒30 mL或葡萄酒90 mL]），或基线时酒精呼气试验阳性，或拒绝整个研究期间停止饮酒或摄入任何含酒精制品； 21.筛选前6个月内和/或筛选期、基线使用过含烟草或尼古丁的产品（包括香烟、烟斗、雪茄、尼古丁贴剂或尼古丁胶），且平均每日吸烟> 4支，或拒绝在整个研究期间避免使用含烟草或尼古丁的产品（包括电子烟）； 22.在研究给药（Day 1）前7天内食用了圣·约翰草（贯叶连翘）、葡萄柚、石榴或蔓越莓及相关制品，芥末绿蔬菜（如西兰花、豆瓣菜、羽衣甘蓝、芽甘蓝、芥末），或拒绝在整个研究期间避免食用此类物质； 23.在研究给药（Day 1）前3天（72小时）内摄入了含咖啡因或黄嘌呤的产品/药物（例如咖啡、茶、可乐饮料、其他含咖啡因的饮料或巧克力、动物内脏、海鲜、浓肉汤或肉汁等），或拒绝在整个研究期间避免摄入此类产品或药物； 检查评估 24.血肌酐> ULN，或估算的肾小球滤过率（eGFR）< 90 mL/min/1.73 m^2； 25.血清梅毒螺旋体特异性抗体阳性、艾滋病病毒（HIV）抗体阳性，或丙肝（HCV）抗体阳性，或乙肝表面抗原（HBsAg）阳性； 其他 26.正在参加任何其他临床研究，或在基线前3个月内或先前给予的试验药物的5个半衰期（源自先前试验最后一次研究程序[采血或给药]的日期）内暴露于其他试验药物者，以时间较长者为准； 27.正处于怀孕或母乳喂养的女性； 28.对饮食有特殊要求，或不能遵守统一饮食； 29.静脉采血困难（如有晕针、晕血史），或研究者认为静脉条件差，不适合入组者； 30.筛选访视前3个月内献血或失血>= 400 mL，或接受了输血或使用血制品；或计划在研究期间献血或血液成份。

Exclusion criteria：

History of allergies 1. Those who are allergic to the active ingredients of the drug or their excipients in this study or contraindicated in use; 2. Have a significant history of multiple and/or severe allergies, including food allergies (Note: Participants with seasonal allergies may be allowed to participate, except for those with persistent symptoms). Medical history/medical condition 3. History of depression or post-traumatic stress disorder within 2 years prior to the screening visit; or have suicidal behavior or suicidal tendencies; or suicidal tendencies judged by the investigator (psychiatrist can be asked for evaluation if necessary), which may increase the risk of participating in the study, and is not suitable for participation in the study according to the judgment of the investigator; 4. Severe infectious diseases (if hospitalization or parenteral antibiotic therapy or opportunistic infections are required) within 6 months prior to screening, or a history of chronic or recurrent infectious diseases; 5. Within 3 months prior to screening, with symptomatic herpes zoster or herpes simplex; 6. Trauma or major surgical surgery within 3 months prior to screening, or surgery that may significantly affect the safety evaluation, or planned abdominal surgery during the course of the study; 7. History of infection and/or fever within 7 days prior to screening; 8. Previous lymphoproliferative disorders; 9. First-degree relatives with hereditary immunodeficiency diseases; 10. Previous history of venous thromboembolism (VTE) or coagulation dysfunction; 11. Has a history or current condition of other significant metabolic, infectious or cardiovascular, gastrointestinal, hepatic, renal/urinary, respiratory, endocrine, hematological, immunologic, neurological, reproductive system, dermatologic, malignant tumors (except basal cell carcinoma of the skin and cervical cancer in situ that have been resected and no evidence of recurrence) or psychiatric illness requiring medication and/or other treatment, including dietary restriction and physical therapy, which in the opinion of the investigator is not suitable for participation in this study; 12. Any previous condition that may affect drug absorption (e.g., gastric banding/gastrectomy, cholecystectomy, bowel resection) and/or duodenal disease (i.e., celiac disease) (except for appendectomy); 13. Previous or current presence of the following cardiac risk factors: a. Torsades de pointes or its risk factors, including use of drugs with delayed cardiac repolarization, hypokalemia, hypomagnesemia, and history of heart failure, bradycardia, cardiomyopathy, long QT syndrome b. 12-lead ECG measured in the supine position at rest for at least 10 minutes, resulting in a corrected QTcF interval of > 450 msec [corrected by Fridericia's formula, QTcF = QT (RR.-1/3) c. Orthostatic hypotension, unexplained syncope, myocardial infarction, angina, pulmonary congestion, and arrhythmias such as QT interval prolongation or conduction abnormalities, sick sinus syndrome and second- or third-degree atrioventricular block, family or personal history of A-S syndrome or Brugada syndrome Prior/concomitant therapy 14. Received vaccination within 6 weeks prior to study dosing, or planned to receive vaccination at any time during the treatment period or within 8 weeks after study completion, or, will have frequent contact with people vaccinated with live virus or live attenuated virus vaccine within 2 months after the end of study dosing; 15. Use of drugs or substances known to be CYP3A inducers or inhibitors within 1 month prior to baseline (see Appendix 2); 16. Have used any prescription drugs or over-the-counter drugs (including Chinese herbal medicines, vitamins, minerals and dietary supplements, etc.) within 14 days or at least 5 half-lives before the study dosing (Day 1), whichever is longer; 17. Ineffective previous treatment with TYK2 inhibitors; 18. May require the treatment of prohibited medications or treatments specified in this study for the duration of the study; Drug abuse, alcohol, tobacco or nicotine, dietary restrictions 19. History of drug abuse within 6 months prior to screening and/or during the screening period, or positive urine drug test during the screening period or baseline; 20. History of alcohol abuse within 6 months prior to screening and/or during the screening period (alcoholism refers to average daily alcohol consumption > 2 units of alcohol [1 unit = 240 mL of beer or 30 mL of liquor with 40% alcohol or 90 mL of wine]), or a positive alcohol breath test at baseline, or refusal to stop drinking alcohol or ingest any alcohol-containing products throughout the study period; 21. Use of tobacco or nicotine-containing products (including cigarettes, pipes, cigars, nicotine patches, or nicotine gum) within 6 months prior to screening and/or during the screening period, baseline, and an average daily smoking > 4 cigarettes, or refusal to refrain from using tobacco or nicotine-containing products (including e-cigarettes) throughout the study; 22. Consumption of St. John's wort (St. John's wort (St. John's wort perforatus), grapefruit, pomegranate or cranberry and related products, mustard green vegetables (such as broccoli, watercress, kale, Brussels sprouts, mustard) within 7 days prior to study dosing (Day 1), or refusal to avoid consuming such substances throughout the study period; 23. Intake of caffeinated or xanthine-containing products/drugs (e.g., coffee, tea, cola drinks, other caffeinated beverages or chocolate, animal offal, seafood, thick broth or gravy, etc.) within 3 days (72 hours) prior to study dosing (Day 1), or refusal to avoid ingesting such products or drugs throughout the study; Check the assessment 24. Serum creatinine > ULN, or estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m^2; 25. Positive serum Treponema pallidum specific antibody, HIV antibody, hepatitis C (HCV) antibody, or hepatitis B surface antigen (HBsAg) positive; other 26. Those who are participating in any other clinical study, or have been exposed to other trial drugs within 3 months prior to baseline or within 5 half-lives (from the date of the last study procedure [blood collection or administration] of the previous trial), whichever is longer; 27. Women who are pregnant or breastfeeding; 28. Have special dietary requirements, or cannot follow a uniform diet; 29. Those who have difficulty in venous blood collection (such as a history of needle sickness or blood sickness), or those who are considered by the investigator to have poor venous conditions and are not suitable for enrollment; 30. Blood donation or blood loss > = 400 mL within 3 months prior to the screening visit, or received a blood transfusion or use of blood products; or plan to donate blood or blood components during the study.

研究实施时间：

Study execute time：

从 From 2024-05-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-27 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

SAD研究（第一部分）

样本量：

 44

Group：

SAD Study (Part I)

Sample size：

干预措施：

SAD研究计划在2.5 - 200 mg范围内取6个剂量进行分组递增：2.5、7.5、25、75、150、200 mg。符合条件的健康成年受试者将被分配至6个递增剂量组中的一个，并在空腹状态下接受CMS-D001或安慰剂单次口服给药。

干预措施代码：

Intervention：

The SAD study is planned to be grouped in 6 doses in the range of 2.5 - 200 mg: 2.5, 7.5, 25, 75, 150, 200 mg. Eligible healthy adult subjects will be assigned to one of 6 ascending dose groups and receive either CMS-D001 or placebo as a single oral dose in an fasting state.

Intervention code：

组别：

MAD研究（第二部分）

样本量：

 24

Group：

MAD Study (Part II)

Sample size：

干预措施：

根据 Part-1 SAD 研究的结果，并结合非临床药效研究数据，选择 3 个安全且预期有效的剂量进行 MAD 安全性、耐受性剂量递增队列研究，拟设剂量为 50 mg、100 mg\150~200（该范围内选择一个剂量） mg。MAD 研究包括 4 周筛选期、10 天给药期和 1 周随访。

干预措施代码：

Intervention：

According to the results of the Part-1 SAD study, combined with the data of the non-clinical efficacy study, 3 safe and expected effective doses were selected for the MAD safety, tolerability dose escalation cohort study, and the proposed doses were 50 mg, 100 mg150~200 (one dose was selected within the range) mg. The MAD study consists of a 4-week screening period, a 10-day dosing period, and a 1-week follow-up period.

Intervention code：

组别：

FE研究（第三部分）

样本量：

 12

Group：

FE Studies (Part III)

Sample size：

干预措施：

研究参与者随机分配到2个队列中，分别在空腹或高脂餐后接受给药。餐后给药时，高脂早餐应在开始进食后30min内完成，并应在进食开始后30min给药。FE研究的样本量将根据 SAD队列中PK数据的变异性来确定。研究参与者将在第一周期给药前一天晚上(Day-1)入住研究中心病房，禁食至少10小时后在Day1单次口服CMS-D001。研究参与者将被要求待在研究中心，直到完成第二周期给药和PK血样采集，经安全性评估后可出院。此时FE研究结束。FE研究两个周期之间的清洗期至少3天，清洗期将根据SAD新出现的PK数据进行调整。当清洗期需要延长时，在完成第一周期后受试者可出院。

干预措施代码：

Intervention：

Study participants were randomly assigned to 2 cohorts to receive dosing after fasting or high-fat meals, respectively. When administering after meals, a high-fat breakfast should be completed within 30 minutes of starting eating, and should be administered 30 minutes after the start of eating. The sample size of the FE study will be determined based on the variability of the PK data in the SAD cohort. Study participants will be admitted to the study center ward the night before the first cycle dosing (Day-1) and will be fasted for at least 10 hours after a single oral dose of CMS-D001 on Day 1. Study participants will be asked to stay at the study center until the completion of the second cycle of dosing and PK blood sample collection, and can be discharged after safety assessment. At this point, the FE study ends. The washout period between the two cycles of the FE study is at least 3 days, and the washout period will be adjusted based on emerging PK data from SAD. When the washout period needs to be extended, the subject can be discharged after completing the first cycle.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 武汉市金银潭医院（武汉市传染病医院） 

单位级别：

 三甲 

Institution
hospital：

Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Part-1 SAD & Part-2 MAD：评价单次或多次口服CMS-D001的安全性和耐受性

指标类型：

主要指标

Outcome：

Part-1 SAD & Part-2 MAD:To evaluate the safety and tolerability of single or multiple oral doses of CMS-D001

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Part-1 SAD & Part-2 MAD：评价单次或多次口服CMS-D001的药代动力学（PK）特征

指标类型：

次要指标

Outcome：

Part-1 SAD & Part-2 MAD:To evaluate the pharmacokinetic (PK) profile of single or multiple oral doses of CMS-D001

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Part-1 SAD & Part-2 MAD：评价单次或多次口服CMS-D001的药效动力学（PD）特征

指标类型：

附加指标

Outcome：

Part-1 SAD & Part-2 MAD:To evaluate the pharmacodynamic (PD) profile of single or multiple oral doses of CMS-D001

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Part-1 SAD & Part-2 MAD：考察血浆中的代谢产物/特征

指标类型：

附加指标

Outcome：

Part-1 SAD & Part-2 MAD:Examine metabolites/signatures in plasma

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Part-1 SAD & Part-2 MAD：评价口服CMS-D001对心脏QT间期的影响

指标类型：

附加指标

Outcome：

Part-1 SAD & Part-2 MAD:To evaluate the effect of oral administration of CMS-D001 on cardiac QT interval

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Part-3：FE：评价食物对单次口服CMS-D001暴露量的影响

指标类型：

主要指标

Outcome：

Part-3: FE: To assess the effects of food on exposure to CMS-D001 in a single oral dose

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Part-3：FE：评价空腹或餐后条件下单次口服CMSD001的安全性和耐受性

指标类型：

次要指标

Outcome：

Part-3: FE:To assess the safety and tolerability of single oral CMSD001 in fasting or postprandial conditions

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 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）：

随机分配表由生物统计人员应用SAS统计软件（9.4及以上版本）产生。

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

The random allocation table is generated by biostatisticians using SAS statistical software (version 9.4 and above).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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，通过ResMan(www.medresman.org.cn)方式共享

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

After the end of the study, it was shared by ResMan (www.medresman.org.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：

CRF;EDC

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

CRF;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-04-02 10:23:27