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：	ChiCTR2600125775
最近更新日期： Date of Last Refreshed on：	2026-05-31 22:55:34
注册时间： Date of Registration：	2026-05-31 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项在健康试验参与者中评价注射用HYH2006078P1单次静脉给药安全性、耐受性和药代动力学的随机、双盲、安慰剂/阳性对照、剂量爬坡的Ⅰ期临床研究
Public title：	A randomized, double-blind, placebo/active-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of a single intravenous dose of HYH2006078P1 in healthy trial participants.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项在健康试验参与者中评价注射用HYH2006078P1单次静脉给药安全性、耐受性和药代动力学的随机、双盲、安慰剂/阳性对照、剂量爬坡的Ⅰ期临床研究
Scientific title：	A randomized, double-blind, placebo/active-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of a single intravenous dose of HYH2006078P1 in healthy trial participants.
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 8665
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
Applicant's institution：	Xiangya Third 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：	Xiangya Third 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：	26103	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：	IRB,theThird Xiangya Hospital of Central South University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-23 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号中南大学湘雅三医院伦理委员会
Contact Address of the ethic committee：	IRB,the Third Xiangya Hospital of Central South University.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：

Xiangya Third Hospital of 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 City, Hunan Province, 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：	Hunan	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 City, Hunan Province, China

经费或物资来源：

天地恒一制药股份有限公司

Source(s) of funding：

Hinye Pharmaceutical Co.,Ltd.

研究疾病：

疼痛

Target disease：

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：评价健康成年试验参与者单次静脉注射不同给药剂量注射用HYH2006078P1的安全性和耐受性。次要目的：评价健康成年试验参与者单次静脉注射不同给药剂量注射用HYH2006078P1的药物代谢动力学（PK）特性。探索性目的：如果数据足够且可行，初步探索评价健康试验参与者单次静脉注射不同给药剂量注射用HYH2006078P1药效动力学（PD）（镇静麻醉深度评分和/或BIS值）特征，初步探索剂量-暴露-效应之间的关系，并与丙泊酚乳状注射液和安慰剂进行比较，为后续临床研究制定安全有效合理的给药方案提供依据。进行c-QTcF研究，探索浓度和QTcF间的关系。

Objectives of Study：

Primary Objective: To evaluate the safety and tolerability of single intravenous administration of different doses of 006078P1 for injection in healthy adult subjects. Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of single intravenous administration of different doses f HYH2006078P1 for injection in healthy adult subjects. Exploratory Objective: If data are sufficient and feasible, to preliminarily explore the pharmacodynamic (PD) n-anesthesia depth scores and/or BIS values) characteristics of single intravenous administration of different doses of HYH2006078P1 for injection in healthy subjts, preliminarily explore the relationship between dose, exposure, and effect, and compare with Propofol Emulsion Injection and placebo, to provide a basis for formulating safe, efd reasonable dosing regimens for subsequent clinical studies. To conduct a c-QTcF study to explore the relationship between concentrati

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

排除标准：

1.已知对鸡蛋、豆制品、丙泊酚乳状注射液中的辅料、注射用HYH2006078P1或辅料（磺丁基倍他环糊精钠、枸橼酸、枸橼酸钠）过敏者；有药物过敏史（包括麻醉药品）、过敏性疾病、属过敏体质者。 2.既往有通气困难或怀疑是困难气道或预估气管插管困难者（比如改良的Mallampti 评分Ⅲ-Ⅳ级，先天性口小舌大、下颌骨发育不良等）。 3.筛选前1个月内接受过灭活疫苗接种，筛选前3个月内接受过灭活/减毒疫苗接种或计划在试验期间接受灭活/减毒疫苗接种者。 4.具有深度镇静/全身麻醉禁忌证者或既往曾出现过镇静/麻醉意外史者。 5.筛选/入组前使用了以下任何一种药物或治疗：1)筛选期前3个月内有药物滥用史，长期服用精神类药物或有任何显示长期使用苯二氮卓类药物的迹象（如失眠、焦虑、痉挛），或尿中药物筛查（筛选期或基线期）结果呈阳性者；2) 筛选前3个月内参加过任何药物或医疗器械的临床试验；3) 入组前2周内使用过除避孕药、扑热息痛、口服非甾体类抗炎药物、局部非处方的外用制剂外的任何处方药物、中草药、非处方药或食物补充剂，如维生素、钙补充剂；除非主要研究者（PI）和申办方共同认为所用药物对本试验安全性和PK/PD结果没有影响方可入组。 6.筛选前4周有严重外伤或外科大手术者。 7.筛选前有以下任何一种疾病的病史或证据：1)有心血管系统疾病史如：高血压病、严重心律失常、心力衰竭、缺血性心脏病、阿-斯综合征（Adams-Stokes综合征）、需药物治疗的心动过速或过缓、男性QTcF间期＞＝450ms/女性QTcF间期＞＝460ms（按Fridericia’s公式校正）；2) 呼吸系统病史：有呼吸功能不全、睡眠呼吸暂停综合征、阻塞性肺部疾病史、哮喘史或筛选前3个月内出现需治疗的支气管痉挛史、基线期前1周患上急性呼吸道感染且有明显症状者；3)脑血管病史：颅脑损伤、可能存在惊厥、肌阵挛、颅内高压、脑动脉瘤、脑血管意外病史者；精神分裂症、躁狂症、精神错乱、认知功能障碍病史等；基线期前1周患上急性颅内感染且有明显症状者；4)胃肠道病史：胃肠道潴留、活动性出血、可能导致返流误吸等情况；基线期前1周患上急性胃肠道感染且有明显症状者；5)未控制的具有显著临床意义肝脏、肾脏、血液系统、神经系统或代谢系统等研究者判断可能不适合参加研究的疾病史。 8.筛选前3个月内每日吸烟量≥5支者或不能在研究期间禁用任何烟草类产品者。 9.筛选期前3个月内有酒精滥用史（定义为每日规律饮用酒精超过以下标准：即每周饮酒超过14单位酒精（1单位=360 mL 酒精含量为5%的啤酒或45 mL酒精量为40%的烈酒或150 mL酒精量为12%的葡萄酒），或酒精浓度检测（基线期）阳性者。 10.入组前30天内献血或失血≥200mL；入组前7天内献血或者进行血浆置换者。 11.入组前2天内不禁烟酒或食用含黄嘌呤或咖啡因的食物或饮料，剧烈运动或有其他影响药物吸收、分布、代谢、排泄等因素者；给药前10小时不能空腹者。 12.预期试验期间可能有手术或者住院倾向者。 13.妊娠和哺乳期女性；具有生育能力的女性或男性不愿意在整个试验期间避孕。 14.采血困难、不能耐受静脉穿刺和/或有晕血、晕针史者。 15.研究者认为具有任何不宜参加此试验因素者。

Exclusion criteria：

1. Individuals with a known allergy to eggs, soy products, excipients in Propoon Injection, HYH2006078P1 for Injection, or excipients (sulfobutylether β-cyclodextrin sodium, acid, sodium citrate); individuals with a history of drug allergy (including anesthetic drugs), allergic diseases, or a constitution prone to allergies. 2. Individuals with a history of difficultntilation or suspected difficult airway, or those predicted to have difficulty with tracheal intubation (e.g., Modified Mallampati score III-IV, micrmia with macroglossia, mandibular hypoplasia, etc.). 3. Individuals who received inactivated vaccination within 1 month prior to screening, or received ctivated/attenuated vaccination within 3 months prior to screening, or plan to receive inactivated/attenuated vaccination during the trial. 4. Individuals with contraindicat to deep sedation/general anesthesia, or a history of adverse events during sedation/anesthesia. 5. Individuals who used any of the following drugs or treatments prior to screening/erollment: 1) History of drug abuse within 3 months prior to the screening period, long-term use of psychotropic drugs, or any signs of long-term use of benzoiazepines (e.g., insomnia, anxiety, spasms), or positive results in urine drug screening (during the screening period or baseline period); 2) Participated in any clinical tr of drugs or medical devices within 3 months prior to screening; 3) Used any prescription drugs, Chinese herbal medicines, over-the-counter drugs, or food supplements (e.gins, calcium supplements) other than oral contraceptives, acetaminophen, oral non-steroidal anti-inflammatory drugs, and topical over-the-counter preparations within 2 weeks prior t enrollment; unless the Principal Investigator (PI) and the Sponsor jointly determine that the medication used has no impact on the safety and PK/PD results of this trial, enrollment s allowed. 6. Individuals with a history of severe trauma or major surgery within 4 weeks prior to screening. 7. Individuals with a history or evidence of any of the following diseases prior o screening: 1) History of cardiovascular diseases such as: hypertension, severe arrhythmia, heart failure, ischemic heart disease, Adams-Stokes syndrome, tacardia or bradycardia requiring medication, or male QTcF interval >=450ms/female QTcF interval >=460ms (corrected bFridericia's formula); 2) History of respiratory diseases: respiratory insufficiency, sleep apnea syndrome, history of obstructive lung disease, asthma, or history of sm requiring treatment within 3 months prior to screening, or acute respiratory infection with obvious symptoms within 1 week prior to baseline; 3) History of cerebrovascular diseases:head injury, possible seizures, myoclonus, intracranial hypertension, cerebral aneurysm, history of cerebrovascular accident; history of schizophrenia, ia, delirium, cognitive dysfunction, etc.; or acute intracranial infection with obvious symptoms within 1 week prior to baseline; 4) History of gastrointestinal diseases: gastrointestinal retenive bleeding, or conditions that may lead to reflux aspiration; or acute gastrointestinal infection with obvious symptoms within 1 week prior to baseline; 5) Uncontrolled diseases with significant clinical sicance, such as liver, kidney, hematological, neurological, or metabolic diseases, which the investigator judges may make the individual unsuitable for participation in the study. 8. Individualwho smoked ≥5 cigarettes per day within 3 months prior to screening, or cannot abstain from any tobacco products during the study. 9. History of alcohol abuse within 3 months prior to the screening period (defined as regular daily alcohol consumption exceeding the following standards: i.rinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of sirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content)), or positive alcohol concentration test (at baseline). 10. Blood donatr blood loss ≥200 mL within 30 days prior to enrollment; blood donation or plasma exchange within 7 days prior to enrollment. 11. Consumption of alcohol tobacco, or foods/beverages containing xanthines or caffeine within 2 days prior to enrollment; engaging in strenuous exercise or having other factors affecting drug absorption, distribution, meolism, or excretion; inability to fast for 10 hours prior to dosing. 12. Subjects expected to require surgery or hospitalization during the study period. Pregnant or lactating women; women of childbearing potential or men unwilling to use contraception throughout the study. 14. Difficulty in blood sampling, inability to tolerate venipuncturer history of blood or needle phobia. 15. Subjects deemed by the investigator to have any factors unsuitable for participation in this trial.

研究实施时间：

Study execute time：

从 From 2026-04-23 00:00:00至 To 2026-10-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2026-10-31 00:00:00

干预措施：

Interventions：

组别：	0.025mg/kg	样本量：	3
Group：	Group 1:0.025 mg/kg	Sample size：	3
干预措施：	受试者D1早晨给药前，空腹称量排空尿液后的体重，按照体重计算给药量，空腹状态下经上肢静脉1 min内泵注给药，仅单次给药。	干预措施代码：
Intervention：	On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting; the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.	Intervention code：

组别：	0.05 mg/kg（含2例安慰剂）	样本量：	6
Group：	Group 1:0.05 mg/kg(including 2 placebo cases and 2 positive controls)	Sample size：	6
干预措施：	受试者D1早晨给药前，空腹称量排空尿液后的体重，按照体重计算给药量，空腹状态下经上肢静脉1 min内泵注给药，仅单次给药。	干预措施代码：
Intervention：	On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting; the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.	Intervention code：

组别：	0.1 mg/kg（含2例安慰剂及2例阳性对照）	样本量：	12
Group：	Group 1:0.1 mg/kg(including 2 placebo cases and 2 positive controls)	Sample size：	12
干预措施：	受试者D1早晨给药前，空腹称量排空尿液后的体重，按照体重计算给药量，空腹状态下经上肢静脉1 min内泵注给药，仅单次给药。阳性对照组给与丙泊酚乳状注射液2mg/kg。	干预措施代码：
Intervention：	On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting; the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.The positive control group was given Propofol Injectable Emulsion at 2 mg/kg.	Intervention code：

组别：	0.2 mg/kg（含2例安慰剂及2例阳性对照）	样本量：	12
Group：	Group 1:0.2 mg/kg(including 2 placebo cases and 2 positive controls)	Sample size：	12
干预措施：	受试者D1早晨给药前，空腹称量排空尿液后的体重，按照体重计算给药量，空腹状态下经上肢静脉1 min内泵注给药，仅单次给药。阳性对照组给与丙泊酚乳状注射液2mg/kg。	干预措施代码：
Intervention：	On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting; the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.The positive control group was given Propofol Injectable Emulsion at 2 mg/kg.	Intervention code：

组别：	0.3 mg/kg（含2例安慰剂及2例阳性对照）	样本量：	12
Group：	Group 1:0.3 mg/kg(including 2 placebo cases and 2 positive controls)	Sample size：	12
干预措施：	受试者D1早晨给药前，空腹称量排空尿液后的体重，按照体重计算给药量，空腹状态下经上肢静脉1 min内泵注给药，仅单次给药。阳性对照组给与丙泊酚乳状注射液2mg/kg。	干预措施代码：
Intervention：	On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting; the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.The positive control group was given Propofol Injectable Emulsion at 2 mg/kg.	Intervention code：

组别：	0.4 mg/kg（含2例安慰剂）	样本量：	5
Group：	Group 1:0.4 mg/kg (Including 2 cases of placebo)	Sample size：	5
干预措施：	受试者D1早晨给药前，空腹称量排空尿液后的体重，按照体重计算给药量，空腹状态下经上肢静脉1 min内泵注给药，仅单次给药。	干预措施代码：
Intervention：	On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting; the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.	Intervention code：

组别：	0.5mg/kg（含2例安慰剂）	样本量：	5
Group：	Group 1:0.5 mg/kg (Including 2 cases of placebo)	Sample size：	5
干预措施：	受试者D1早晨给药前，空腹称量排空尿液后的体重，按照体重计算给药量，空腹状态下经上肢静脉1 min内泵注给药，仅单次给药。	干预措施代码：
Intervention：	On Day 1, prior to morning dosing, Subject D1 was weighed after voiding while fasting; the dose was calculated based on body weight, and the drug was admired via intravenous infusion in the upper limb within 1 minute under fasting conditions, with only a single dose administered.	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)：
Country：	China	Province：	Human	City：
单位(医院)：	中南大学湘雅三医院	单位级别：	三甲
Institution hospital：	Third Xiangya Hospital, Central South University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	12-导联心电图指标	指标类型：	主要指标
Outcome：	12-lead electrocardiogram 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：	生命体征	指标类型：	主要指标
Outcome：	Vital signs	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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

指标中文名：	睫毛反射	指标类型：	次要指标
Outcome：	Eyelash reflex	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	改良警觉镇静评分	指标类型：	次要指标
Outcome：	Modified Observer's Assessment of Alertness/Sedation (MOAA/S) 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：	脑电双频指数	指标类型：	次要指标
Outcome：	Bispectral Index	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	定向力恢复时间	指标类型：	次要指标
Outcome：	Time to recovery of orientation	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	改良Aldrete评分	指标类型：	次要指标
Outcome：	Modified Aldrete score	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：

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：	Fecal	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	49	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）：

试验参与者按顺序进行随机，队列1试验参与者均分配到试验药物组；队列2试验参与者按照1：2的比例随机分配到安慰剂组、试验药物组；队列3、队列4、队列5试验参与者按照1：4：1分配到安慰剂组、试验药物组和阳性药组；队列6、队列7试验参与者按照2：3分配到安慰剂组、试验药物组。由统计专员使用SAS软件进行随机分组。

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

Trial participants are randomized in sequence; participants in Cohort 1 are all assigned to the trial drug group; participants in Cohort 2 are rando the placebo group and the trial drug group in a 1:2 ratio; participants in Cohorts 3, 4, and 5 are assigned to the placebo groupl drug group, and positive control drug group in a 1:4:1 ratio; participants in Cohorts 6 and 7 are randomized to the placebo group and the triarug group in a 2:3 ratio.Randomization was performed by a statistician using SAS software.

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，对研究参与者和研究者设盲
Blinding：	Double-blind, with both the research participants and the researchers being blinded.

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 researcher or their authorized CRC accesses the data management system through an independent account to conduct data collection. Data management: The data manager designs the eCRF according to the protocol. The eCRF includes all the data points stipulated in the protocol except for external data. The eCRF is directly exported from the EDC system (in PDF format).
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-05-31 22:55:30