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：	ChiCTR2500108201
最近更新日期： Date of Last Refreshed on：	2025-08-26 17:15:30
注册时间： Date of Registration：	2025-08-26 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项随机、双盲、安慰剂对照、单次递增剂量的Ia期临床研究，评价健康成人受试者皮下注射Neu-001的安全性、耐受性和药代动力学特征
Public title：	A randomized, double-blind, placebo-controlled, single dose phase Ia study to investigate the safety, tolerability, pharmacokinetics of Neu-001 following subcutaneous injection in healthy adult participants
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项随机、双盲、安慰剂对照、单次递增剂量的Ia期临床研究，评价健康成人受试者皮下注射Neu-001的安全性、耐受性和药代动力学特征
Scientific title：	A randomized, double-blind, placebo-controlled, single dose phase Ia study to investigate the safety, tolerability, pharmacokinetics of Neu-001 following subcutaneous injection in healthy adult 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：	张华堂	研究负责人：	丁雪鹰
Applicant：	Zhang Huatang	Study leader：	Ding Xueying
申请注册联系人电话： Applicant telephone：	+86 182 4499 8144	研究负责人电话： Study leader's telephone：	+86 137 6164 2319
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：	huatangzhang@neudirection.com	研究负责人电子邮件： Study leader's E-mail：	dingxueying@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：	深圳市福田区福田街道岗厦社区彩田路3069号星河世纪A栋2308H16	研究负责人通讯地址：	上海市虹口区武进路85/86号
Applicant address：	2308H16, Tower A, Xinghe Century, 3069 Caitian Rd, Gangxia, Futian, Shenzhen, Guangdong, China	Study leader's address：	No. 85/86 Wujin Road, Hongkou District, Shanghai
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：	神瞻医药(深圳)有限公司
Applicant's institution：	Shenzhan Pharmaceutical (Shenzhen) Co., Ltd
研究负责人所在单位：	上海市第一人民医院
Affiliation of the Leader：	Shanghai First People's 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：	院伦审[2025]133号	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：	上海市第一人民医院人体试验伦理审查委员会
Name of the ethic committee：	Shanghai General Hospital Institutional Review Board
伦理委员会批准日期： Date of approved by ethic committee：	2025-07-23 00:00:00
伦理委员会联系人：	耿倩雯
Contact Name of the ethic committee：	Geng Qianwen
伦理委员会联系地址：	上海市海宁路100号
Contact Address of the ethic committee：	No. 100 Haining Road, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 3612 6254	伦理委员会联系人邮箱： Contact email of the ethic committee：	shiyilunli@sina.com

研究实施负责（组长）单位：

上海市第一人民医院

Primary sponsor：

Shanghai First People's Hospital

研究实施负责（组长）单位地址：

上海市虹口区武进路85/86号

Primary sponsor's address：

No. 85/86 Wujin Road, Hongkou District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市第一人民医院	具体地址：	上海市虹口区武进路85/86号
Institution hospital：	Shanghai First People's Hospital	Address：	No. 85/86 Wujin Road, Hongkou District, Shanghai

经费或物资来源：

神瞻医药(深圳)有限公司

Source(s) of funding：

Shenzhan Pharmaceutical (Shenzhen) Co., Ltd

研究疾病：

弱视

Target disease：

Amblyopia

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：

评估健康成人受试者单次皮下注射（ SC） Neu 001的安全性和耐受性。评估健康成人受试者单次皮下注射（ SC Neu 001的药代动力学PK 特征。评估健康成人受试者单次皮下注射（ SC） Neu 001后对长时记忆的影响。

Objectives of Study：

To evaluate the safety and tolerability of a single subcutaneous (SC) administration of Neu 001 in healthy adult subjects. To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous (SC) administration of Neu 001 in healthy adult subjects. To evaluate the effects on long-term memory following a single subcutaneous (SC) administration of Neu 001 in healthy adult subjects.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Fully understand the trial's purpose, nature, procedures, and potential adverse reactions; volunteer to participate as a subject; and have signed the informed consent form.
2. Aged between 18 and 45 years (inclusive, based on the date of signing the informed consent form); both sexes are eligible.
3. Body Mass Index (BMI) between 19.0 and 30.0 kg/m^2(inclusive) at screening; male weight ≥ 50 kg, female weight ≥ 45 kg.
4. The investigator judges the subject to be in good general health based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory test results (hematology, urinalysis, blood biochemistry, coagulation function), with findings being normal or showing clinically non-significant abnormalities.
5. Female subjects must be non-pregnant, non-lactating, and have a negative pregnancy test result at screening.
6. From screening until 3 months after the last dose, female and male subjects must voluntarily use reliable, highly effective contraceptive methods. Both male and female subjects must not donate sperm or ova during the study and for 3 months after the last dose.
7. Results of intraocular pressure examination, slit-lamp examination, and fundoscopy are normal or show clinically non-significant abnormalities.
8. Best Corrected Visual Acuity (BCVA) of 1.0 in both eyes.

排除标准：

出现以下任一排除标准的受试者不得入组本试验： 1.有特定过敏史（如荨麻疹）或为过敏体质（如已知对两种或以上物质过敏）者，或经研究者判断可能会对试验用药品或试验用药品中的任何成分过敏者； 2.既往存在慢性疾病史或严重疾病史者，包括但不限于神经、心血管、血液、肝脏、肾脏、胃肠道、呼吸、代谢、内分泌、免疫、骨骼系统疾病或存在其它研究者认为不适合参加本研究的情况者； 3.筛选前一年内存在腹痛、腹胀、腹泻等慢性消化道相关病史者； 4.给药前 1个月内任一眼患有感染、外伤等眼部疾病（如过敏性结膜炎、疱疹性角膜炎、虹膜炎、葡萄膜炎等）者； 5.既往存在焦虑症、抑郁症、强迫症、恐慌症、恐高症等症状或精神疾病史者； 6.筛选前 2周内任一眼使用过角膜接触镜，或本研究期间不能停用角膜接触镜者； 7.筛选前 5年内曾有药物滥用史或筛选前 3个月使用过毒品，或筛选期药物滥用筛查阳性者； 8.筛选前 3个月内平均每日吸烟量大于 5支或习惯性使用含尼古丁制品者； 9.筛选前 3个月内平均每周饮酒量大于 14单位酒精（ 1单位酒精 =360 mL啤酒或 45 mL酒精含量为 40%的烈酒或 150 mL葡萄酒）或接受试验用药品前 48 h服用过含酒精的制品，或基线期酒精呼气测试阳性者； 10. 接受试验用药品前 6个月内患过具有临床意义的重大疾病或接受过重大外科手术，或在试验期间预期需要进行重大手术者； 11. 接受试验用药品前 28天至试验结束，受试者不得使用任何诱导或抑制肝脏代谢酶的药物； 12.接受试验用药品前 14天内使用过任何处方药、非处方药、中草药或保健品者； 13.接受试验用药品前 14天内使用过任何眼部、皮肤等局部用药者； 14.接受试验用药品前 7天内进食过任何含有可诱导或抑制肝脏代谢酶的食物或饮料（如西柚等）者 15.接受试验用药品前 48 h内进食过任何含有或代谢后产生咖啡因或黄嘌呤食物或饮料（如咖啡、茶、可乐、巧克力）者； 16.筛选期病毒血清学检测结果显示，人类免疫缺陷病毒抗体（ HIV Ab）阳性、乙型肝炎表面抗原（ HBsAg）阳性、丙型肝炎抗体 HCV Ab）阳性、或者梅毒螺旋体抗体（ TP Ab）阳性的受试者； 17.有晕针、晕血史者，采血困难或不能耐受静脉穿刺采血者； 18.接受试验用药品前 3个月内参加过其它的药物临床试验并使用过其他临床试验用药者； 19.筛选前 3个月内有献血行为者， 6个月内献血或其他原因失血总和达到或超过 400 mL者（女性生理期失血除外），或计划在研究期间或研究结束后 3个月内献血者； 20.其它任何研究者认为可能影响受试者提供知情同意或遵循试验方案的情况，或受试者参加试验可能影响试验结果或自身安全的情况。

Exclusion criteria：

Subjects with any of the following exclusion criteria shall not be enrolled in this trial: 1. Those who have a history of specific allergies (such as urticaria) or have allergies (such as known allergies to two or more substances), or may be allergic to the investigational drug or any component of the investigational drug as judged by the investigator; 2. Those who have a history of chronic diseases or serious diseases in the past, including but not limited to neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal system diseases or other conditions that the investigator deems unsuitable for participating in this study; 3. Those who have a history of chronic gastrointestinal tract related diseases such as abdominal pain, bloating, and diarrhea within one year before screening; 4. Those who suffer from infection, trauma and other eye diseases (such as allergic conjunctivitis, herpetic keratitis, iritis, uveitis, etc.) in any eye within 1 month before administration; 5. Those who have symptoms such as anxiety, depression, obsessive-compulsive disorder, panic disorder, fear of heights, or a history of mental illness; 6. Those who have used contact lenses in any eye within 2 weeks before screening, or cannot stop using contact lenses during this study; 7. Those who have a history of drug abuse within 5 years before screening or drug use in 3 months before screening, or have a positive drug abuse screen during the screening period; 8. Those who smoke more than 5 cigarettes per day or habitually use nicotine-containing products within 3 months before screening; 9. Those who have drunk an average of more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits or 150 mL of wine with an alcohol content of 40%) or have taken alcohol-containing products in the 48 hours before receiving the test drug, or have a positive alcohol breath test at baseline; 10. Those who have suffered from clinically significant major diseases or undergone major surgical procedures within 6 months before receiving the investigational drug, or who are expected to need major surgery during the trial; 11. From 28 days before receiving the investigational drug to the end of the trial, the subject shall not use any drugs that induce or inhibit liver metabolic enzymes; 12. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products within 14 days before receiving the investigational drug; 13. Those who have used any topical drugs such as eyes and skin within 14 days before receiving the investigational drug; 14. Those who have eaten any food or drink containing enzymes that can induce or inhibit liver metabolism (such as grapefruit, etc.) within 7 days before receiving the investigational drug 15. Those who have eaten any food or beverage containing or metabolized caffeine or xanthines (such as coffee, tea, cola, chocolate) within 48 hours before receiving the test drug; 16. Subjects with positive human immunodeficiency virus antibody (HIV Ab), positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody HCV Ab), or Treponema pallidum antibody (TP Ab) positive during the screening period; 17. Those who have a history of needle sickness and hemosickness, and those who have difficulty or cannot tolerate venipuncture blood collection; 18. Those who have participated in other drug clinical trials and used other clinical trial drugs within 3 months before receiving the investigational drug; 19.Those who have donated blood within 3 months before screening, those who have donated blood or other reasons within 6 months and the total blood loss reaches or exceeds 400 mL (except for female menstrual blood loss), or those who plan to donate blood during the study period or within 3 months after the end of the study; 20. Any other situation that the investigator believes may affect the subject's provision of informed consent or compliance with the trial protocol, or that the subject's participation in the trial may affect the trial results or their own safety.

研究实施时间：

Study execute time：

从 From 2025-08-20 00:00:00至 To 2025-12-15 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-08-26 00:00:00 至 To 2025-11-04 00:00:00

干预措施：

Interventions：

组别：	Neu-001组	样本量：	40
Group：	Neu-001 group	Sample size：	40
干预措施：	8个剂量组： 0.002mg，0.005mg, 0.01mg, 0.03mg, 0.06mg, 0.12mg, 0.2mg ,0.3mg. 进行单次皮下注射给药，观察至给药后48 h。	干预措施代码：
Intervention：	Eight dose groups: 0.002 mg, 0.005 mg, 0.01 mg, 0.03 mg, 0.06 mg, 0.12 mg, 0.2 mg, and 0.3 mg. A single subcutaneous injection will be administered, and observation will continue until 48 hours after dosing.	Intervention code：

组别：	安慰剂组	样本量：	13
Group：	Placebo group	Sample size：	13
干预措施：	8个剂量组，每个剂量组注射于试验药物组等体积灭菌注射用水，给药途径为皮下注射，观察至给药后48 h。	干预措施代码：
Intervention：	Eight dose groups, with each group receiving a subcutaneous injection of sterile water for injection in the same volume as the test drug group, and observation continued until 48 hours after dosing.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市第一人民医院	单位级别：	三甲
Institution hospital：	Shanghai First People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	生命体征（血压、脉搏、体温）	指标类型：	主要指标
Outcome：	Vital signs (blood pressure, pulse, temperature, breathing)	Type：	Primary 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：	主要指标
Outcome：	Physical examination	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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

指标中文名：	临床实验室检查（血常规、血生化、尿常规、凝血功能）	指标类型：	主要指标
Outcome：	Clinical laboratory tests (hematology, urinalysis, blood chemistry and coagulation test)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	眼科检查	指标类型：	主要指标
Outcome：	Ophthalmologic examinations	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	注射部位反应评估	指标类型：	主要指标
Outcome：	Injection site observation	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良事件（ AE））/严重不良事件（ SAE）	指标类型：	主要指标
Outcome：	Adverse events (AEs) / Serious adverse events (SAEs)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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

指标中文名：	长时记忆评分	指标类型：	附加指标
Outcome：	Long-term memory test	Type：	Additional 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	45	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）：

受试者根据筛选合格的顺序给予入组号，入组号由1位剂量组号+3位剂量组内的入组顺序号组成，如队列1入组号编码范围为1001~1002，队列2入组号编码范围为2001~2003，其他剂量组以此类推。队列2~8的受试者入组号由独立统计师采用区组随机化方法产生，独立统计师采用SAS 9.4的PLAN过程。队列1入组2例受试者，2例受试者均接受Neu-001，不涉及随机分组。队列2入组3例受试者，3例受试者按Neu-001:安慰剂=2:1随机接受Neu-001或安慰剂。队列3~8各入组8例，每个队列选取两名受试者作为哨兵并按Neu-001:安慰剂=1:1随机接受Neu-001或安慰剂，队列3~8每队列除哨兵外的受试者按Neu-001:安慰剂=5:1随机接受Neu-001或安慰剂。为确保该随机数据具有重现性，需要保存所设定的随机数初值种子参数。

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

Subjects are assigned study identifiers based on the order of screening qualification. The study identifier consists of a 1-digit dose group number followed by a 3-digit sequential number within the dose group. For example, Cohort 1 study identifiers range from 1001 to 1002, while Cohort 2 ranges from 2001 to 2003. Subsequent dose groups follow the same coding pattern.For Subjects in Cohorts 2–8, study identifiers are generated by an independent statistician using blocked randomization via the PLAN procedure in SAS 9.4. Cohort 1 includes 2 subjects who all receive Neu-001, with no randomization involved. Cohort 2 enrolls 3 subjects randomized in a 2:1 ratio (Neu-001 to placebo).Cohorts 3–8 each enroll 8 subjects. In each cohort, 2 subjects are designated as sentinel cases and randomized in a 1:1 ratio (Neu-001 to placebo). The remaining subjects in Cohorts 3–8 (excluding the sentinel cases) are randomized in a 5:1 ratio (Neu-001 to placebo).To ensure reproducibility of the randomization data, the initial seed value parameters for the random number generation must be preserved.

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：

本试验为双盲研究，研究者、申办者，申办者授权人（如有）和受试者等试验相关人员均不知治疗药物的分配情况（双盲）。在研究结束之前，盲底将不能揭盲给研究者或受试者。将由不直接参与研究的独立统计师生成入组号。与本研究直接相关的所有其他人员（例如，研究者、临床试验机构人员、CRO人员、申办者人员）将保持盲态，直到研究完成，研究完成后将统一揭盲。如疑似触发终止剂量递增标准，可在相关数据冻结后揭盲，用于判定是否触发剂量递增终止标准。

Blinding：

The trial is designed as a double-blind study. All trial personnel, including investigators, sponsors, sponsors’ authorized representatives (if applicable), and subjects, remain unaware of the treatment drug assignments (double-blind). Blinding codes will remain concealed from investigators and subjects until the completion of the study. Subject identifiers will be generated by an independent statistician who is not directly involved in the conduct of the study. All other personnel directly associated with the study (e.g., investigators, clinical trial site staff, CRO personnel, sponsor personnel) will remain blinded to treatment allocation until the study is completed, after which unblinding will be conducted uniformly at the study conclusion. In the case of suspected activation of dose-escalation termination criteria, unblinding may occur after the relevant data is frozen to assess whether the dose-escalation termination criteria have been triggered.

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：	研究者应当确保所有临床试验数据是从临床试验的源文件和试验记录中获得的，是准确、完整、可读和及时的。源数据应当具有可归因性、易读性、同时性、原始性、准确性、完整性、一致性和持久性。源数据的修改应当留痕，不能掩盖初始数据，并记录修改的理由。本试验数据管理由申办者指定的数据管理部门负责，本试验使用电子数据采集（Electronic Data Capture，EDC）系统。根据数据管理计划（Data Management Plan，DMP）和数据核查计划（Data Verification Plan，DVP）对系统数据进行管理和核查。数据管理部门根据方案设计eCRF。研究者或者研究者指定人员根据原始数据准确、完整、及时地填写eCRF。数据管理员对录入EDC系统的数据进行逻辑核查（Edit Check），保证数据的准确性。数据管理过程中应保存所有的稽查轨迹（Audit Trail）。数据管理员对疑问数据提出质疑（Query），所有质疑得到解决，研究者对每一份eCRF进行电子签名（Electronic Signature）确认。申办者负责人、研究者、项目经理、数据管理人员和统计分析师等共同审核数据。最终数据库锁定（Database Lock），对文件进行归档。锁定的数据库一般不得解锁（Database Unlock），如需解锁时，提交申请由主要研究者、项目经理、数据管理人员和统计分析师等人员共同签署。数据库的再次锁定应遵循和数据库首次锁定一样的通知/批准过程。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Investigators should ensure that all clinical trial data is obtained from the source documents and trial records of the clinical trial and is accurate, complete, readable and timely. Source data should be attributable, legible, concurrent, original, accurate, complete, consistent, and durable. The modification of the source data should leave traces, cannot cover up the initial data, and record the reason for the modification. The data management of this trial is the responsibility of the data management department designated by the sponsor, and the trial uses an electronic data capture (EDC) system. Manage and verify system data according to the Data Management Plan (DMP) and Data Verification Plan (DVP). The data management department designs the eCRF according to the scheme. The investigator or investigator's designee completes the eCRF accurately, completely, and in a timely manner based on the original data. The data manager performs a logical edit check on the data entered into the EDC system to ensure the accuracy of the data. All audit trails should be kept in the process of data management. The data manager questions the questioned data, all the questions are resolved, and the researcher confirms each eCRF with an electronic signature. The sponsor leader, researcher, project manager, data manager, and statistical analyst jointly review the data. Final Database Lock, which archives files. Locked databases are generally not allowed to be unlocked, and if they need to be unlocked, the application must be signed by the principal investigator, project manager, data manager, and statistical analyst. Re-locking of a database should follow the same notification/approval process as the first lock of the database.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-08-26 17:15:25