ChiCTR2600122999 版本V1.0 版本创建时间2026/04/20 17:57:11 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：

 ChiCTR2600122999 

最近更新日期：

Date of Last Refreshed on：

 2026-04-20 17:57:06 

注册时间：

Date of Registration：

 2026-04-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

注射用RGL-236在膝骨关节炎患者中单次和多次给药的安全性、耐受性、免疫原性、药代动力学特征及初步有效性的I期临床试验

Public title：

Phase I Clinical Trial to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetic Characteristics and Preliminary Efficacy of RGL-236 for Injection Following Single and Multiple Doses in Patients with Knee Osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

注射用RGL-236在膝骨关节炎患者中单次和多次给药的安全性、耐受性、免疫原性、药代动力学特征及初步有效性的I期临床试验

Scientific title：

Phase I Clinical Trial to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetic Characteristics and Preliminary Efficacy of RGL-236 for Injection Following Single and Multiple Doses in Patients with Knee Osteoarthritis

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：

乔宇 

研究负责人：

刘璠 

Applicant：

Yu Qiao 

Study leader：

Pan Liu 

申请注册联系人电话：

Applicant telephone：

 +86 183 1713 1565

研究负责人电话：

Study leader's
telephone：

+86 139 0148 2027

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：

 yu.qiao.yq18@regenelead.com

研究负责人电子邮件：

Study leader's E-mail：

 liufan19575@aliyun.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：

上海市浦东新区联创路399号

研究负责人通讯地址：

江苏省南通市崇川区西寺路20号

Applicant address：

No. 399, Lianchuang Road, Pudong New Area, Shanghai P.R. China

Study leader's address：

No. 20 Xisi Road, Chongchuan District, Nantong City, Jiangsu 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：

上海瑞宏迪医药有限公司

Applicant's institution：

Shanghai Regenelead Therapies Co., Ltd.

研究负责人所在单位：

南通大学附属医院

Affiliation of the Leader：

Affiliated hospital of Nantong 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：

 2026-Y108-02

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：

南通大学附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Nantong University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-13 00:00:00

伦理委员会联系人：

张妞

Contact Name of the ethic committee：

Niu Zhang

伦理委员会联系地址：

江苏省南通市西寺路20号

Contact Address of the ethic committee：

No. 20 Xisi Road, Nantong City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 513 8505 2390

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：

南通大学附属医院

Primary sponsor：

Affiliated hospital of Nantong University

研究实施负责（组长）单位地址：

江苏省南通市崇川区西寺路20号

Primary sponsor's address：

No. 20 Xisi Road, Chongchuan District, Nantong City, Jiangsu 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)：

江苏省

市(区县)：

南通市

Country：

China

Province：

Jiangsu Province

City：

Nantong

单位(医院)：

南通大学附属医院

具体地址：

江苏省南通市崇川区西寺路20号

Institution
hospital：

Affiliated hospital of Nantong University

Address：

No. 20 Xisi Road, Chongchuan District, Nantong City, Jiangsu Province

经费或物资来源：

上海瑞宏迪医药有限公司、广州瑞领医药有限公司

Source(s) of funding：

Shanghai Regenelead Therapies Co., Ltd. ; Guangzhou Revolead Therapies Co., Ltd.

研究疾病：

膝骨关节炎  

Target disease：

Knee Osteoarthritis

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RGL-236在膝骨关节炎受试者中关节腔内注射的安全性和耐受性。 评估RGL-236在膝骨关节炎受试者中关节腔内注射的药代动力学（PK）特征。 评估RGL-236在膝骨关节炎受试者中关节腔内注射的免疫原性。  

Objectives of Study：

To evaluate the safety and tolerability of intra-articular injection of RGL-236 in subjects with knee osteoarthritis. To evaluate the pharmacokinetic (PK) profile of intra-articular injection of RGL-236 in subjects with knee osteoarthritis. To evaluate the immunogenicity of intra-articular injection of RGL-236 in subjects with knee osteoarthritis.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

受试者必须符合以下所有标准才能入选本研究。 1. 受试者必须能够理解和与研究者沟通，能够遵守研究要求，自愿参加本研究并书面签署知情同意书。 2. 年龄为40 ~75 岁（含两端）的男性和女性。 3. 身体质量指数（BMI）< 30 kg/m^2。 4. 研究侧膝关节诊断为原发性膝骨关节炎至少6个月（根据2018年版《中国骨关节炎诊疗指南》）。 5. 研究侧膝骨关节炎累及内侧胫股间室，Kellgren-Lawrence（K-L）放射学分级（立位）为2或3级，且非研究侧膝关节分级不得高于研究侧膝关节。 6. 筛选期内研究侧膝关节WOMAC疼痛评分的平均值为15 ~ 45分（共50分），其中第一项“在平地行走的时候”≥4分（共10分），且疼痛至少持续4周。

Inclusion criteria

Subjects must meet all of the following criteria to be enrolled in this study. 1. Subjects must be able to understand and communicate with the investigator, comply with study requirements, volunteer to participate in this study, and provide written informed consent. 2. Male or female subjects aged 40 to 75 years (inclusive). 3. Body mass index (BMI) < 30 kg/m^2. 4. Diagnosed with primary knee osteoarthritis of the study knee for at least 6 months (in accordance with the 2018 edition of Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis). 5. Osteoarthritis of the study knee involves the medial femorotibial compartment, with Kellgren-Lawrence (K-L) radiographic grade (weight-bearing) of 2 or 3; the grade of the non-study knee must not be higher than that of the study knee. 6. Mean WOMAC pain score of the study knee during the screening period is 15 to 45 (total 50 points), with the first item "while walking on level ground" >= 4 points (total 10 points), and pain lasting for at least 4 weeks.

排除标准：

受试者若符合以下任何一项标准，将不得进入本研究。 1. 非研究侧膝骨关节炎的K-L放射学分级为4级。 2. 研究侧膝关节严重的膝内/外翻畸形。 3. 筛选前4周内进行研究侧膝关节电疗法、针灸等治疗。 4. 筛选前12周进行过研究侧膝关节腔内注射中短效皮质类固醇激素、玻璃酸钠关节腔内注射、麻醉制剂等或系统性糖皮质激素治疗。 5. 筛选前6个月内关节腔内注射富血小板血浆或长效皮质类固醇激素。 6. 筛选前4周内或筛选期间研究侧膝关节有中-重度炎症的临床表现（即发红、发热、积液），或临床上需要对研究侧膝关节进行穿刺抽液。 7. 既往曾对研究侧膝关节腔内进行过手术或计划在试验期间进行膝关节手术，其中超过筛选期6月的关节镜清创术、部分半月板切除是允许的。 8. 基于病史和/或体格检查，存在研究侧膝关节不稳定（包括但不限于创伤后或先天性松弛）或韧带重建不充分。 9. 存在由临床评估或影像学证实的其他膝关节病理表现，包括软骨下不全骨折、骨折（筛选前6个月内的急性或亚急性骨折）或骨挫伤、骨坏死、恶性骨髓浸润、实体瘤和/或髌股关节发育不良。 10. 研究侧膝关节注射位点有局部注射禁忌症，例如开放性创伤、银屑病病灶、局部感染等；或研究者判断无法进行膝关节注射的全身疾病或状况，例如凝血功能障碍性疾病、需进行抗凝治疗的等。 11. 筛选期前5个药物半衰期或2周内使用中枢镇痛药物（例如曲马多），麻醉性镇痛药（例如吗啡、杜冷丁和其他阿片类药物）等。 12. 存在可能混淆对研究侧膝骨关节炎相关疼痛评估的其他疼痛情况，如：可能累及关节的全身性疾病、神经疾病、同侧髋关节炎、神经根病型腰椎压迫引起的局部疼痛以及其他任何可能混淆有效性评估的疼痛情况。 13. 筛选时已知其他关节或软骨疾病，自身免疫性疾病伴炎症性关节炎（包括但不限于类风湿关节炎、银屑病关节炎、强直性脊柱炎、系统性红斑狼疮）、晶体性关节炎（痛风、假性痛风性关节炎）、反应性关节炎、活动性急性或慢性膝关节感染或既往膝关节感染、全身性软骨疾病、全身性结缔组织疾病。 14. 既往5年内有恶性肿瘤病史，除外治愈的局部癌症，如局部皮肤基底细胞癌、甲状腺癌等。 15. 已知有任何活动性感染，包括注射部位皮肤感染或膝关节感染或可能损害免疫系统的感染（如HIV感染或活动性HBV感染或HCV感染或梅毒等）。 活动性HBV感染：筛选时乙肝表面抗原（HbsAg）阳性且HBV-DNA病毒载量大于当地医疗机构正常参考范围的上限。 活动性HCV感染：筛选时HCV抗体检测结果和HCV-RNA检测结果均为阳性。 16. 实验室检查异常： 1) 血红蛋白 < 90 g/L或血小板＜100×109/L； 2) 丙氨酸氨基转移酶（ALT）或天门冬氨酸氨基转移酶（AST）＞2.5×正常上限（ULN），或总胆红素＞2×ULN； 3) 血肌酐（Cr）＞1.5×ULN； 4) 凝血常规：国际标准化比值（INR）＞1.5×ULN，活化部分凝血活酶时间（APTT）＞1.5×ULN； 5) 空腹血糖 > 10 mmol/L。 17. 筛选期内未得到良好控制的重大慢性疾病，如未控制的高血压（治疗后收缩压≥180mmHg或舒张压≥110mmHg）、需要干预的严重心律失常、慢性心力衰竭（纽约心脏病协会（NYHA）分级为III 或IV 级）。 18. 筛选前3个月内，发生脑梗死（除外腔隙性梗死）、脑出血、心肌梗死、不稳定性心绞痛的患者。 19. 筛选前3个月内有重大手术史或计划在研究期间进行重大手术。 20. 有对任何一种试验药物或其辅料或与其同类别药物有过敏史，或具有MRI检测禁忌症。 21. 既往有吸毒史或药物滥用史或酗酒史，或确诊有任何精神疾病。 22. 既往使用过基因细胞治疗（包括质粒DNA、基因改造的病毒、细菌或细胞以及基于基因编辑技术的产品等）或参与过基因细胞治疗相关的临床试验。 23. 筛选前1个月内参加过除基因细胞治疗产品以外其他药物干预的临床试验（除外筛选失败者），或者筛选时尚在药物5个半衰期以内（以时间更长者为准）。 24. 一般情况： 1) 不能正确描述症状和情绪/情感者； 2) 无法配合完成试验过程中相关检查和评估。 3) 不同意在研究期间和末次给药后6个月内采用高效避孕措施的男性或女性受试者； 4) 妊娠或哺乳期女性； 5) 研究者判定受试者依从性不佳或具有任何不宜参加此试验的因素，包括但不限于研究会使受试者处于不可接受的风险或可能干扰研究结果，或受试者功能状态差无法进行自我照顾。

Exclusion criteria：

Subjects will not be eligible for this study if they meet any of the following criteria. 1. Kellgren-Lawrence (K-L) radiographic grade of 4 for osteoarthritis of the non-study knee. 2. Severe varus or valgus deformity of the study knee. 3. Administration of physical therapy such as electrotherapy, acupuncture, or similar treatments to the study knee within 4 weeks prior to screening. 4. Intra-articular administration of intermediate- or short-acting corticosteroids, sodium hyaluronate, anesthetic agents, or systemic glucocorticoid therapy to the study knee within 12 weeks prior to screening. 5. Intra-articular injection of platelet-rich plasma (PRP) or long-acting corticosteroids into the study knee within 6 months prior to screening. 6. Clinical evidence of moderate to severe inflammation in the study knee (i.e., redness, warmth, effusion) during the screening period or within 4 weeks prior to screening, or clinical indication for arthrocentesis of the study knee. 7. Previous intra-articular surgery of the study knee, or planned knee surgery during the trial period; arthroscopic debridement or partial meniscectomy performed more than 6 months prior to screening is permitted. 8. Knee instability of the study knee (including but not limited to post-traumatic or congenital laxity) or insufficient ligament reconstruction based on medical history and/or physical examination. 9. Other pathological conditions of the knee confirmed by clinical assessment or imaging, including subchondral insufficiency fracture, fracture (acute or subacute fracture within 6 months prior to screening) or bone contusion, osteonecrosis, malignant bone marrow infiltration, solid tumor, and/or patellofemoral dysplasia. 10. Local contraindications at the injection site of the study knee, such as open wounds, psoriatic lesions, local infection, etc.; or systemic diseases or conditions that, in the investigator's judgment, preclude knee injection, such as coagulation disorders, requirement for anticoagulant therapy, etc. 11. Use of central analgesics (e.g., tramadol), narcotic analgesics (e.g., morphine, pethidine, and other opioids) within 5 elimination half-lives of the respective drug or 2 weeks prior to screening, whichever is longer. 12. Other painful conditions that may confound the assessment of pain associated with knee osteoarthritis of the study knee, including systemic diseases potentially involving joints, neurological disorders, ipsilateral hip arthritis, localized pain caused by radicular lumbar compression, and any other painful conditions that may interfere with efficacy evaluation. 13. Other known joint or cartilage diseases at screening, autoimmune diseases with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal arthritis (gout, pseudogout arthritis), reactive arthritis, active acute or chronic knee infection or previous knee infection, systemic chondropathy, systemic connective tissue disease. 14. History of malignant tumor within the past 5 years, except for cured localized cancers such as localized basal cell carcinoma of the skin, thyroid cancer, etc. 15. Any known active infection, including skin infection at the injection site, knee infection, or infections that may impair the immune system (e.g., HIV infection, active HBV infection, active HCV infection, syphilis, etc.): (1) Active HBV infection: positive hepatitis B surface antigen (HBsAg) at screening with HBV-DNA viral load above the upper limit of the normal reference range of the local medical institution. (2) Active HCV infection: both positive HCV antibody test and positive HCV-RNA test at screening. 16. Abnormal laboratory findings: (1) Hemoglobin < 90 g/L or platelet count < 100×10^9/L; (2) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × upper limit of normal (ULN), or total bilirubin > 2 × ULN; (3) Serum creatinine (Cr) > 1.5 × ULN; (4) Coagulation tests: international normalized ratio (INR) > 1.5 × ULN, activated partial thromboplastin time (APTT) > 1.5 × ULN; (5) Fasting blood glucose > 10 mmol/L. 17. Uncontrolled major chronic diseases during the screening period, such as uncontrolled hypertension (systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg despite treatment), severe arrhythmia requiring intervention, chronic heart failure (New York Heart Association (NYHA) functional class III or IV). 18. History of cerebral infarction (excluding lacunar infarction), cerebral hemorrhage, myocardial infarction, or unstable angina pectoris within 3 months prior to screening. 19. History of major surgery within 3 months prior to screening, or planned major surgery during the study period. 20. History of hypersensitivity to any investigational product, its excipients, or drugs of the same class; or contraindications to MRI examination. 21. History of drug addiction, substance abuse, or alcoholism, or diagnosis of any psychiatric disorder. 22. Previous use of gene or cell therapy (including plasmid DNA, genetically modified viruses, bacteria or cells, and products based on gene-editing technology, etc.) or participation in clinical trials related to gene or cell therapy. 23. Participation in another clinical trial involving investigational medicinal products (excluding failed screenings) within 1 month prior to screening, or still within 5 elimination half-lives of the study drug at the time of screening, whichever is longer. 24. General conditions: (1) Inability to accurately describe symptoms and mood/emotions; (2) Inability to cooperate with relevant examinations and assessments during the trial; (3) Male or female subjects unwilling to use highly effective contraceptive measures during the study period and for 6 months after the last dose; (4) Pregnant or lactating female subjects; (5) Subjects judged by the investigator to have poor compliance or any other factors unsuitable for participation in this trial, including but not limited to situations where participation would expose the subject to unacceptable risk, may interfere with study results, or subjects with poor functional status unable to perform self-care.

研究实施时间：

Study execute time：

从 From 2026-04-12 00:00:00至 To 2027-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-20 00:00:00 至 To 2026-08-13 00:00:00

干预措施：

Interventions：

组别：

单次给药递增组

样本量：

 12

Group：

Single ascending dose group

Sample size：

干预措施：

RGL-236

干预措施代码：

Intervention：

RGL-236

Intervention code：

组别：

多次给药递增组

样本量：

 32

Group：

Multiple ascending dose group

Sample size：

干预措施：

RGL-236或0.9%氯化钠注射液

干预措施代码：

Intervention：

RGL-236 or 0.9% Sodium Chloride Injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 南通 

Country：

China

Province：

Jiangsu

City：

Nantong

单位(医院)：

 南通大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated hospital of Nantong University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

不良事件（AE）发生率及其严重程度，以及其他安全性评价（包括生命体征、体格检查、实验室检查、心电图等较基线的变化）

指标类型：

主要指标

Outcome：

Incidence and severity of adverse events (AEs), as well as other safety assessments (including changes from baseline in vital signs, physical examination, laboratory tests, electrocardiography, etc.)

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：

Pharmacokinetics

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抗体的阳性率、滴度值、持续时间

指标类型：

次要指标

Outcome：

Positive rate, titer, and duration of 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：

疗效评分变化

指标类型：

次要指标

Outcome：

Changes in efficacy scores

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 75 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）：

第二部分MAD试验中随机化专员采用SAS软件完成随机分配表与药物编号表的产生，中央随机化系统对符合入选标准的受试者进行随机分组，并根据入组结果给予受试者相应组别的药物治疗

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

In Part 2 (MAD trial), the randomization specialist generated the random allocation table and drug numbering table using SAS software. The central randomization system randomized subjects who met the eligibility criteria into groups and administered the corresponding investigational product to subjects based on the enrollment results.

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：

受试者、研究者、所有参与试验临床操作或评定的医务人员施盲

Blinding：

Subjects, investigators, and all medical personnel involved in clinical trial procedures or assessments are blind

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：

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-04-20 17:57:06