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：	ChiCTR2500113417
最近更新日期： Date of Last Refreshed on：	2025-11-27 17:48:32
注册时间： Date of Registration：	2025-11-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	在中国健康受试者中评价注射用TRD208单次静脉给药的安全性、耐受性、药代动力学及药效动力学特征的 Ia 期临床研究
Public title：	Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Intravenous Administration of TRD208 for Injection in Healthy Chinese Subjects
注册题目简写：
English Acronym：
研究课题的正式科学名称：	在中国健康受试者中评价注射用TRD208单次静脉给药的安全性、耐受性、药代动力学及药效动力学特征的 Ia 期临床研究
Scientific title：	Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Intravenous Administration of TRD208 for Injection in Healthy Chinese 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：	湖南省长沙市岳麓区桐梓坡路138号	研究负责人通讯地址：	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	Study leader's address：	No. 138, Tongzipo Road, Yuelu District, Changsha City, Hunan Province
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
Applicant's institution：	The Third Xiangya Hospital of Central South University
研究负责人所在单位：	中南大学湘雅三医院
Affiliation of the Leader：	The Third Xiangya Hospital of 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：	25131	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：	2025-08-13 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：	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 City, Hunan Province
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临床试验中心

Primary sponsor：

Clinical Trial Center of Third Xiangya Hospital of Central South University

研究实施负责（组长）单位地址：

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 City, Hunan Province

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：	Hunan	City：
单位(医院)：	中南大学湘雅三医院	具体地址：	湖南省长沙市岳麓区桐梓坡路138号
Institution hospital：	Third Xiangya Hospital,Central South Univer	Address：	No. 138, Tongzipo Road, Yuelu District, Changsha City, Hunan Province

经费或物资来源：

北京泰德制药股份有限公司

Source(s) of funding：

Beijing Tide Pharmaceutical Co., Ltd.

研究疾病：

手术后疼痛

Target disease：

Postoperative pain

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：评价健康受试者 TRD208 单次静脉给药后的安全性和耐受性。次要目的：评价健康受试者单次静脉给药后 TRD208 及其代谢产物 M1（TDS0383）和 M2（TDS0367）的药代动力学特征。探索性目的：初步探索健康受试者 TRD208 单次静脉给药后对 QT/QTc 间期的影响；初步探索健康受试者 TRD208 单次静脉给药后的药效动力学特征；初步探索健康受试者单次静脉给药后 TRD208 及其代谢产物 M1（TDS0383）和 M2（TDS0367）的代谢和排泄特征。

Objectives of Study：

Main Objective: Evaluate the safety and tolerability of a single intravenous dose of TRD208 in healthy subjects. Secondary Objective: Evaluate the pharmacokinetic characteristics of TRD208 and its metabolites M1 (TDS0383) and M2 (TDS0367) in healthy subjects following a single intravenous dose. Exploratory Objectives: Preliminarily explore the effect of a single intravenous dose of TRD208 on the QT/QTc interval in healthy subjects; Preliminarily explore the pharmacodynamic characteristics of a single intravenous dose of TRD208 in healthy subjects; Preliminarily explore the metabolic and excretory characteristics of TRD208 and its metabolites M1 (TDS0383) and M2 (TDS0367) in healthy subjects following a single intravenous dose.

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. Before the trial, the subjects had thoroughly understood the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial. They were able to understand the procedures and methods of this study, were willing to strictly abide by the requirements of the entire clinical research, and voluntarily signed the informed consent form.
2. Healthy subjects aged 18 to 55 years old (including the boundary value, based on the time of signing the informed consent form), regardless of gender;
3. The body mass index (BMI) is within the range of 19 to 28 kg/m ² (including the critical value), with a weight of 50 kg for men and 45 kg for women.
4. The subject and his/her partner had no plans to have children, donate sperm or eggs within 6 months from the signing of the informed consent form to the last acceptance of the trial drug, and voluntarily adopted efficient contraceptive measures (see Appendix 2); Female subjects with fertility must undergo serum pregnancy tests during the screening period and baseline period, and the results must be negative.
5. The skin at the site of pain stimulation has no wounds or skin diseases.
6. Those who are willing to undergo pain tests and pass the training.

排除标准：

1.既往或目前患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、血液学、免疫学、精神病学及代谢异常等临床急慢性疾病，经研究者判定不适宜入组者； 2.已知对 NSAIDs类药物过敏或为过敏体质者（对两种或两种以上药物或食物有过敏史）； 3.既往或合并阿司匹林哮喘者； 4.既往或合并有任何增加出血性风险的疾病，如痔疮、急性胃炎或胃及十二指肠溃疡等； 5. 筛选期或基线期：天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、总胆红素、血肌酐超过正常范围上限者，或经研究者判定异常且有临床意义的高钾血症、低钾血症者； 6. 既往有尖端扭转型室性心动过速病史、症状性室性心律失常，或有短 QT综合征、长 QT 综合征个人史或家族史者； 7.既往或合并下列疾病者，心血管疾病[如心力衰竭（如液体潴留和水肿）、不稳定性缺血性心脏病、充血性心力衰、控制不佳的冠状动脉疾病、心肌梗死等； 8. 签署 ICF前 6 个月内有严重感染、外伤或接受过重大手术者，或既往接受过可能显著影响研究药物药动学特征或安全性评价的手术者（如肝肾移植术），或计划在试验期间进行手术者； 9.给药前 1个月内使用过任何抑制或诱导肝脏对药物代谢的药物（如：诱导剂—巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑；抑制剂— SSRI 类抗抑郁药、西咪替丁、地尔硫卓、大环内酯类、硝基咪唑类、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类）者； 10.签署 ICF 前 1 个月内接种过疫苗或计划在试验期间接种疫苗者； 11.给药前 7 个半衰期内或 14 天内（以时间较长者为准）使用过任何药物或保健品（包括中草药）者，或筛选期已知试验期间可能需要接受其他药物治疗者； 12.签署 ICF前 3 个月内参加过临床试验并接受了试验药物者，或计划在试验期间参加其他临床试验者； 13.签署 ICF 前 3 个月内献血/失血量>=400 mL（女性生理性失血除外）、接受输血或使用血制品，或计划在试验期间或试验结束后 1 个月内献血者； 14.签署 ICF 前 3 个月内平均每日吸烟量大于 5 支，或试验期间不能戒烟者； 15.签署 ICF 前 3 个月内平均每周饮酒超过 14 单位酒精（1 单位≈285 mL 酒精含量为 3.5%的啤酒，或 25 mL 酒精含量为 40%的烈酒，或 85 mL 酒精含量为 12%的葡萄酒），或不同意试验期间禁酒者； 16.签署 ICF前 3 个月内每天饮用过量茶、咖啡或含咖啡因的饮料（平均每天8 杯以上，1 杯=200 mL）者； 17. 给药前 48 小时内食用特殊食物（如西柚、西柚汁或含西柚汁的食物/饮料、巧克力、烟草、酒精类、含咖啡因类等食物或饮料）者； 18.对饮食有特殊要求，不能遵守统一饮食者； 19.筛选期的体格检查、生命体征检查、12 导联心电图、实验室检查（血常规、尿常规、血生化、凝血功能等）、胸部正位 X 线、腹部 B 超检查结果经研究医生判断为异常有临床意义者； 20.筛选期 12 导联心电图检查存在异常且研究者判定有临床意义者，如心动过缓或心动过速（心率＜60bpm 或＞100bpm，且经研究者判断有临床意义者）、QTc 延长（男性 QTcF 间期>=450 ms，女性 QTcF 间期>=470 ms，按 Fridericia’s 公式校正）、心律失常等； 21.既往或合并低血压或高血压病史，或筛选期收缩压＜90mHg 或＞140mmHg，舒张压＜60mmHg 或＞90mmHg，且经研究者判断有临床意义者； 22.筛选期的乙型肝炎表面抗原、丙型肝炎病毒抗体、梅毒螺旋体抗体或人类免疫缺陷病毒抗原/抗体任意一项检查结果呈阳性者； 23.既往有药物滥用史/毒品使用史者，或药物滥用筛查（包括吗啡、甲基安非他明、氯胺酮、四氢大麻酚酸、亚甲二氧基甲基安非他明）结果呈阳性者； 24.酒精呼气筛查结果为阳性者； 25.静脉采血困难/不能耐受静脉穿刺者，或有晕针/晕血史者； 26.妊娠期或哺乳期女性，或筛选期血妊娠检查结果阳性者； 27.受试者可能因为其他原因而不能完成本研究或研究者认为不适合纳入者（如评估认为受试者对疼痛过于敏感或者极不敏感）。

Exclusion criteria：

1.Those who have previously or currently suffer from acute or chronic clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic disorders, and are determined by the researcher to be unsuitable for enrollment; 2.Those who are known to be allergic to NSAIDs or have an allergic constitution (with a history of allergy to two or more drugs or foods); 3.Those with a history of or combined aspirin asthma; 4.Have any pre-existing or concurrent diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers, etc. 5.Screening period or baseline period: Individuals with aspartate aminotransferase, alanine aminotransferase, total bilirubin, or serum creatinine levels exceeding the upper limit of the normal range, or those with hyperkalemia or hypokalemia that have been identified as abnormal by the researcher and have clinical significance; 6.Those with a history of tortuous pointed-point ventricular tachycardia, symptomatic ventricular arrhythmia, or a personal or family history of short QT syndrome or long QT syndrome; 7.Those with a history or concurrent conditions of the following diseases: cardiovascular diseases [such as heart failure (such as fluid retention and edema), unstable ischemic heart disease, congestive heart failure, poorly controlled coronary artery disease, myocardial infarction, etc.] 8.Those who have had severe infections, trauma or undergone heavy major surgeries within 6 months prior to signing the ICF, or who have previously undergone surgeries that may significantly affect the pharmacokinetic characteristics or safety evaluation of the investigational drug (such as liver or kidney transplantation), or who plan to undergo surgery during the trial period; 9.Within one month prior to administration, any drugs that inhibit or induce liver metabolism of drugs (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors -Patients with SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, and antihistamines; 10.Those who have been vaccinated within one month prior to signing the ICF or plan to be vaccinated during the trial period; 11.Those who have used any drugs or health supplements (including Chinese herbal medicines) within 7 half-lives or 14 days (whichever is longer) before administration, or those who have known during the screening period that they may need to receive other drugs during the trial period"Physical therapist;" 12.Those who have participated in clinical trials and received the trial drugs within three months prior to signing the ICF, or those who plan to participate in other clinical trials during the trial period; 13. Those who have donated or lost at least 400 mL of blood within 3 months prior to signing the ICF (excluding physiological blood loss in women), received a blood transfusion or used blood products, or plan to donate blood during the trial or within 1 month after the trial ends; 14.Those who smoked an average of more than five cigarettes per day in the three months prior to signing the ICF, or were unable to quit smoking during the trial period; 15.Those who consumed an average of more than 14 units of alcohol per week in the three months prior to signing the ICF (1 unit ≈285 mL of beer with an alcohol content of 3.5%, or 25 mL of spirits with an alcohol content of 40%, or 85 mL of wine with an alcohol content of 12%), or who do not agree to abban alcohol during the trial period; 16.Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 8 cups per day, 1 cup =200 mL) every day within the three months prior to signing the ICF; 17.Those who have consumed special foods (such as grapefruit, grapefruit juice or foods/beverages containing grapefruit juice, chocolate, tobacco, alcohol, caffeine-containing foods or beverages, etc.) within 48 hours before administration; 18. Those who have special dietary requirements and cannot follow the uniform diet; 19.Physical examination during the screening period, vital sign examination, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.), anteroposterior chest X-ray, abdominal B-ultrasound examination and conclusion. If, after research, the doctor determines that it is abnormal and has clinical significance; 20.Those with abnormalities in 12-lead electrocardiogram examination during the screening period and determined by the researchers to have clinical significance, such as bradycardia or tachycardia (heart rate < 60bpm or > 100bpm, and determined by the researchers to have clinical significance), and QTc prolongation (male QTcF interval >=450 ms) Female QTcF interval >=470 ms (corrected according to Fridericia's formula), arrhythmia, etc. 21.Those with a history of hypotension or hypertension, or with a systolic blood pressure of less than 90mHg or more than 140mmHg and a diastolic blood pressure of less than 60mmHg or more than 90mmHg during the screening period, and who are judged by the researcher to have clinical significance; 22.Those who test positive for any one of the hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antigen/antibody during the screening period. 23.Those with a history of drug abuse or drug use, or who test positive in drug abuse screening (including morphine, methamphetamine, ketamine, tetrahydrocannabinic acid, and methylene dimethoxymethamphetamine) Sex; 24.Those with positive results in alcohol breath screening; 25.Those who have difficulty in venous blood collection or cannot tolerate venipuncture, or have a history of fainting at the sight of needles or blood; 26.Pregnant or lactating women, or those with positive results in blood pregnancy tests during the screening period; 27.Subjects who may not be able to complete this study for other reasons or who the researchers consider unsuitable for inclusion (such as those assessed as overly sensitive or extremely insensitive to pain).

研究实施时间：

Study execute time：

从 From 2025-09-12 00:00:00至 To 2026-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-11-28 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：	10 mg（TRD208）	样本量：	6
Group：	10 mg(TRD208)	Sample size：	6
干预措施：	单次静脉给药，静脉输液泵输注10 mgTRD208，输注时间为 30min±5min，输注体积为100ml。	干预措施代码：
Intervention：	Single intravenous administration, with 10 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.	Intervention code：

组别：	30 mg（TRD208）	样本量：	8
Group：	30 mg(TRD208)	Sample size：	8
干预措施：	单次静脉给药，静脉输液泵输注30 mgTRD208，输注时间为 30min±5min，输注体积为100ml。	干预措施代码：
Intervention：	Single intravenous administration, with 30 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.	Intervention code：

组别：	60 mg（TRD208）	样本量：	8
Group：	60 mg(TRD208)	Sample size：	8
干预措施：	单次静脉给药，静脉输液泵输注60 mgTRD208，输注时间为 30min±5min，输注体积为100ml。	干预措施代码：
Intervention：	Single intravenous administration, with 60 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.	Intervention code：

组别：	120 mg（TRD208）	样本量：	8
Group：	120 mg(TRD208)	Sample size：	8
干预措施：	单次静脉给药，静脉输液泵输注120 mgTRD208，输注时间为 30min±5min，输注体积为100ml。	干预措施代码：
Intervention：	Single intravenous administration, with 120 mg of TRD208 or placebo infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.	Intervention code：

组别：	200 mg（TRD208）	样本量：	8
Group：	200 mg(TRD208)	Sample size：	8
干预措施：	单次静脉给药，静脉输液泵输注200 mgTRD208，输注时间为 30min±5min，输注体积为100ml。	干预措施代码：
Intervention：	Single intravenous administration, with 200 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.	Intervention code：

组别：	300 mg（TRD208）	样本量：	6
Group：	300 mg(TRD208)	Sample size：	6
干预措施：	单次静脉给药，静脉输液泵输注300 mgTRD208，输注时间为 30min±5min，输注体积为100ml。	干预措施代码：
Intervention：	Single intravenous administration, with 300 mg of TRD208 infused through an intravenous infusion pump over a period of 30 minutes ± 5 minutes, with an infusion volume of 100 ml.	Intervention code：

组别：	10 mg（安慰剂）	样本量：	2
Group：	10 mg(placebo)	Sample size：	2
干预措施：	单次静脉给药，静脉输液泵输注安慰剂，输注时间为 30min±5min，输注体积为100m（2.2ml灭菌注射用水+97.8m生理盐水）。	干预措施代码：
Intervention：	Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml of saline).	Intervention code：

组别：	30 mg（安慰剂）	样本量：	2
Group：	30 mg(placebo)	Sample size：	2
干预措施：	单次静脉给药，静脉输液泵输注安慰剂，输注时间为 30min±5min，输注体积为100m（2.2ml灭菌注射用水+97.8m生理盐水）。	干预措施代码：
Intervention：	Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml of saline).	Intervention code：

组别：	60 mg（安慰剂）	样本量：	2
Group：	60 mg(placebo)	Sample size：	2
干预措施：	单次静脉给药，静脉输液泵输注安慰剂，输注时间为 30min±5min，输注体积为100m（2.2ml灭菌注射用水+97.8m生理盐水）。	干预措施代码：
Intervention：	Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml of saline).	Intervention code：

组别：	120 mg（安慰剂）	样本量：	2
Group：	120 mg(placebo)	Sample size：	2
干预措施：	单次静脉给药，静脉输液泵输注安慰剂，输注时间为 30min±5min，输注体积为100m（2.2ml灭菌注射用水+97.8m生理盐水）。	干预措施代码：
Intervention：	Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml of saline).	Intervention code：

组别：	200 mg（安慰剂）	样本量：	2
Group：	200 mg(placebo)	Sample size：	2
干预措施：	单次静脉给药，静脉输液泵输注安慰剂，输注时间为 30min±5min，输注体积为100m（2.2ml灭菌注射用水+97.8m生理盐水）。	干预措施代码：
Intervention：	Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml of saline).	Intervention code：

组别：	300 mg（安慰剂）	样本量：	2
Group：	300 mg(placebo)	Sample size：	2
干预措施：	单次静脉给药，静脉输液泵输注安慰剂，输注时间为 30min±5min，输注体积为100m（2.2ml灭菌注射用水+97.8m生理盐水）。	干预措施代码：
Intervention：	Single intravenous administration, placebo infused via an IV infusion pump, infusion time of 30 min ± 5 min, infusion volume of 100 ml (2.2 ml of sterile water for injection and 97.8 ml of saline).	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：	Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	药代动力学指标	指标类型：	主要指标
Outcome：	Pharmacokinetic indicators	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	心电图	指标类型：	次要指标
Outcome：	Electrocardiogram	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血压	指标类型：	次要指标
Outcome：	Blood pressure	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	体格检查	指标类型：	次要指标
Outcome：	Physical examination	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：	粪样	组织：
Sample Name：	Fecal sample	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：	尿样	组织：
Sample Name：	Urine	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation 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）：

本试验计划设置 6 个剂量组，分别为 10mg、30mg、60mg、120mg、200mg、300 mg。10mg 剂量组采用哨兵法入组，先纳入 2 例受试者，按 1:1 的比例随机分别接受 TRD208 或安慰剂，安全性观察≥3 天，由研究者对受试者进行安全性评估，安全性和耐受性良好的情况下，再纳入其余 6 例受试者，按 5:1 的比例随机分别接受 TRD208 或安慰剂。其余剂量组根据前一剂量组的安全性评估之后决定是否采用哨兵法入组，若使用哨兵法，前 2 例受试者采用 1:1（试验组：安慰剂组）进行完全随机，剩余受试者采用 7:1 或 5:1（试验组：安慰剂组）进行完全随机；若不使用哨兵法，则其余剂量组采用 4:1 或 3:1（试验组：安慰剂组）进行完全随机。每个剂量组受试者的随机号由独立于项目的随机化统计师采用SAS 软件（9.4 或以上版本）的 PLAN 过程产生随机表，将为每个剂量组研究各生成两个随机化表，根据情况选择。研究中生成的随机数具有重现性，所设定的随机数初值种子参数等记录在盲底中。

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

This trial plans to set up six dose groups, namely 10mg, 30mg, 60mg, 120mg, 200mg and 300mg. The 10mg dose group was enrolled using the sentinel method. First, 2 subjects were included and randomly assigned in a 1:1 ratio to receive TRD208 or placebo respectively. The safety observation lasted for ≥3 days. The researchers evaluated the safety of the subjects. If the safety and tolerance were good, the remaining 6 subjects were included. Randomly receive TRD208 or placebo in a 5:1 ratio respectively. For the remaining dose groups, the decision on whether to use the sentinel method for enrollment was made based on the safety assessment of the previous dose group. If the sentinel method was used, the first two subjects were completely randomized in a 1:1 ratio (experimental group: placebo group), and the remaining subjects were completely randomized in a 7:1 or 5:1 ratio (experimental group: placebo group). If the sentinel method is not used, the remaining dose groups will be completely randomized using 4:1 or 3:1 (experimental group: placebo group). The random number of each dose group subject was generated by a randomization statistician independent of the project using the PLAN process of SAS software (version 9.4 or above) to produce a randomization table. Two randomization tables will be generated for each dose group study, and the selection will be made as needed. The random numbers generated in the study have reproducibility. The initial values, seed parameters, etc. of the set random numbers are recorded in the blind background.

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：	双盲，受试者及除非盲团队（进行试验用药品的包装、配制、配制过程的监查）的研究者均处于盲态
Blinding：	Double-blind: both the subjects and the researchers, except for the unblinded team (responsible for packaging, preparing the investigational drugs, and monitoring the preparation process), are blinded.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
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: The data is collected by the researcher or his authorized CRC through a separate account into the data management system. Data Management: The data administrator designs the eCRF according to the scheme. The eCRF contains all the data points specified in the scheme except the external data. The eCRF(PDF format) is directly exported by the 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：	2025-11-27 17:48:25