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：	ChiCTR2600120535
最近更新日期： Date of Last Refreshed on：	2026-03-16 17:29:30
注册时间： Date of Registration：	2026-03-16 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	一项在纤维化性间质性肺病（F-ILD）患者中评价卟硒啉片的安全性和有效性的多中心、随机、双盲、安慰剂对照的IIb期临床试验
Public title：	A multiple-center, randomized, double-blind, placebo-controlled phase IIb clinical trial evaluating the safety and efficacy of standard treatment in combination with butaselen tablets in patients with fibrosing interstitial lung disease
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项在纤维化性间质性肺病（F-ILD）患者中评价卟硒啉片的安全性和有效性的多中心、随机、双盲、安慰剂对照的IIb期临床试验
Scientific title：	A multiple-center, randomized, double-blind, placebo-controlled phase IIb clinical trial evaluating the safety and efficacy of standard treatment in combination with butaselen tablets in patients with fibrosing interstitial lung disease
研究课题代号(代码)： Study subject ID：	YBS-2401
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：	尹汉维	研究负责人：	代华平
Applicant：	Yin Hanwei	Study leader：	Dai Huaping
申请注册联系人电话： Applicant telephone：	+86 189 1142 0767	研究负责人电话： Study leader's telephone：	+86 139 0129 3597
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：	yinhanwei@yxmedicine.com	研究负责人电子邮件： Study leader's E-mail：	daihuaping@sina.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：	中国上海市浦东新区盛夏路608号3幢203	研究负责人通讯地址：	中国北京市朝阳区樱花园东街2号
Applicant address：	203, Building 3, 608 Shengxia Road, Pudong New Area, Shanghai, China	Study leader's address：	2 Yinghuayuan East Street, Chaoyang District, Beijing, China
申请注册联系人邮政编码： Applicant postcode：	201203	研究负责人邮政编码： Study leader's postcode：	100029
申请人所在单位：	上海元熙医药科技有限公司
Applicant's institution：	Shanghai Yuanxi Medicine Corp.
研究负责人所在单位：	中日友好医院
Affiliation of the Leader：	China-Japan Friendship 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：	YW2024-090-01	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：	中日友好医院药物（器械）临床试验伦理委员会
Name of the ethic committee：	Clinical Study Ethics Committee of the China-Japan Friendship Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-12-27 00:00:00
伦理委员会联系人：	郤思远
Contact Name of the ethic committee：	Xi Siyuan
伦理委员会联系地址：	中国北京市朝阳区樱花园东街2号
Contact Address of the ethic committee：	2 Yinghuayuan East Street, Chaoyang District, Beijing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 8420 6086	伦理委员会联系人邮箱： Contact email of the ethic committee：	ZRYHYYGCPEC@126.com

研究实施负责（组长）单位：

中日友好医院

Primary sponsor：

China-Japan Friendship Hospital

研究实施负责（组长）单位地址：

中国北京市朝阳区樱花园东街2号

Primary sponsor's address：

2 Yinghuayuan East Street, Chaoyang District, Beijing, 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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海元熙医药科技有限公司	具体地址：	上海市浦东新区盛夏路608号3幢203
Institution hospital：	Shanghai Yuanxi Medicine Corp.	Address：	203, Building 3, 608 Shengxia Road, Pudong New Area, Shanghai

经费或物资来源：

自筹

Source(s) of funding：

Self support

研究疾病：

纤维化性间质性肺病（ F-ILD）

Target disease：

fibrosing interstitial lung disease

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：

II期临床试验

Study phase：

2

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要目的:评估卟硒啉片联合标准治疗或单独治疗在纤维化性间质性肺病患者中的安全性；次要目的:评价卟硒啉片联合标准治疗或单独治疗在纤维化化间质性肺病患者中的有效性

Objectives of Study：

Primary objective:To evaluate the safety of standard treatment in combination with butaselen tablet in patients with fibrotic interstitial lung disease (F-ILD). Secondary objective: To evaluate the efficacy of standard treatment in combination with butaselen tablet in patients with fibrotic interstitial lung disease (F-ILD).

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.Both sexes, aged 18-80 years (inclusive), and written informed consent provided at the time of signing;
2.Disease and conditions:
(1) Diagnosed with fibrotic interstitial lung diseases (F-ILDs) [mainly including non-IPF idiopathic interstitial pneumonias (nonIPF-IIP) (such as idiopathic non-specific interstitial pneumonia (iNSIP), cryptogenic organizing pneumonia (COP), desquamative interstitial pneumonia (DIP), unclassifiable idiopathic interstitial pneumonia (U-IIP)), chronic hypersensitivity pneumonitis (CHP), interstitial pneumonia with autoimmune features (IPAF), chronic eosinophilic pneumonia (CEP), sarcoidosis] for >= 2 months; and with findings of 1) and/or 2) as follows:
1) Fibrosing lung disease affecting greater than 10% of total lung volume on high-resolution computed tomography (HRCT), with radiographic features including: interlobular septal thickening, reticular opacities, traction bronchiectasis/bronchiolectasis, lung structure distortion, honeycombing, with or without ground-glass opacity;
2) Histopathological findings of fibrosis through lung biopsy [transbronchial lung biopsy (TBLB) / transbronchial lung cryobiopsy (TBLC) / video-assisted thoracoscopic surgery (VATS)] including: alveolar septal or interlobular septal widening, fibroblast proliferation, collagen deposition, bronchiolectasis, honeycombing, and lung structure distortion;
(2)Forced vital capacity (FVC) >=45% of predicted value and <= 90% of predicted value, and diffusing capacity of the lung for carbon monoxide (DLCO) >=40% of predicted value at screening and baseline;
3.The participants (including male) do not plan of pregnancy, also who will use effective contraception voluntarily, and do not donate sperm or eggs during the entire period of screening and the trial (details in Appendix 2); 
4.For participants with fibrotic interstitial lung disease receiving corticosteroid therapy as background treatment, they should be treatment-naïve or have previously received conventional regimens (initial dose of prednisone 0.5-0.75 mg/kg/day (20-60 mg/day) or equivalent), and the investigator confirms their ability to adhere to the protocol-specified corticosteroid tapering regimen;
5.The participants understand the procedures and details of this trial and take part in the trial voluntarily with written informed consent; the participants will comply completely with the indications in the trial.

排除标准：

1.过敏体质，或者已知对卟硒啉片或卟硒啉片类似物以及卟硒啉片组分中的任何成分或相关制剂过敏史者，且经研究者判定不宜入组者； 2.诊断为结缔组织疾病相关间质性肺病（CTD-ILD）、血管炎相关间质性肺疾病； 3.筛选时动脉血氧分压（PaO2）<=60mmHg（未吸氧时）； 4.筛选前1个月内和/或筛选期间下呼吸道感染； 5.筛选前1个月内和/或筛选期间间质性肺炎急性加重伴呼吸衰竭； 6.未控制的活动性肺结核，活动性B型、C型肝炎，HIV感染； 7.筛选前1个月内接受规律抗纤维化治疗（定义为吡非尼酮400-600mg，tid，治疗时长>=1月；尼达尼布 100-150mg，bid，治疗时长>=1个月）；抗氧化治疗（乙酰半胱氨酸0.6g，tid，治疗时长>=1个月）； 8.筛选前1月内规律接受免疫抑制剂治疗（不包括糖皮质激素），包括但不限于环磷酰胺、硫唑嘌呤、甲氨蝶呤、环孢素、他克莫司、吗替麦考酚酯、托法替布、巴瑞替尼、托珠单抗等；6个月内接受利妥昔单抗治疗； 9.首次给药前12周内接种过（减毒）活疫苗或计划在研究期间接受任何（减毒）活疫苗（接种过新冠病毒疫苗或新冠病毒疫苗加强剂超过4周者允许入组）； 10.关于既往病史以及现患疾病史，满足以下任一条标准则需排除： (1).受试者无法口服药物，或存在明显的胃肠道吸收障碍； (2).有重度肺动脉高压（心脏超声示三尖瓣反流峰值流速＞3.4m/s），或肺外病理改变（如胸壁畸形、大量胸腔积液）； (3).在筛选前3个月内发生过心肌梗死、心绞痛、经皮冠状动脉腔内血管成形术、冠状动脉搭桥术、心力衰竭（纽约心脏病协会心功能分级＞II级）、短暂性脑缺血发作、脑梗塞、脑出血或蛛网膜下腔出血； (4).目前合并有其他不稳定的心血管疾病（如高血压病经规律治疗3个月后血压未有效控制，收缩压>=160mmHg和/或舒张压>=100mmHg）； (5).既往或现在有恶性肿瘤的受试者（除外在进入研究筛选前5年已达到完全缓解、不需其他治疗方案或预期在研究期间不需要继续治疗的受试者）； (6).筛选前患有心血管、肝脏、肾脏、胃肠道、免疫、内分泌、代谢、精神和/或心理、神经以及血液和淋巴系统疾病，经研究者判断不适合参与本研究； 11.关于辅助检查，满足以下任意一条标准则需排除： (1).血常规：血红蛋白＜90g/L，血小板＜90×10^9/L，白细胞＜2.0×10^9/L； (2).肝功能：谷丙转氨酶或谷草转氨酶或总胆红素＞1.5倍正常值上限； (3).肾功能：肌酐清除率低于60mL/min或血清肌酐>=1.5倍正常上限【实测值，或者Cockcroft-Gault公式计算值（详见附录1）】； (4).传染病检查：活动性乙肝（若HBsAg检测阳性，则进行HBV-DNA检查，HBV-DNA高于检测上限者不允许入组），活动性丙肝（若HCV抗体检测阳性，则进行 HCV-RNA检查，HCV-RNA高于检测上限者不允许入组），或人类免疫缺陷病毒感染者（定义为HIV抗体阳性），或梅毒螺旋体特异性抗体（TP-Ab）检查结果阳性者； (5).甲状腺超声检查结果表明甲状腺影像报告和数据系统（TI-RADS）＞3级（详见附录6）； 12.妊娠或哺乳期的女性，或妊娠试验结果阳性的女性； 13.筛选前3个月（或5个半衰期内，以较长者为准）内接受过其他任何试验药物治疗，或筛选前3个月内参加任何医疗器械的临床试验者； 14.任何其他不宜参加此试验的因素，研究者认为其可能会影响受试者对方案的依从性、干扰研究结果的解释或使受试者暴露于风险。

Exclusion criteria：

1.Allergics, or known allergic history to ingredients in investigational product, and who are not appropriate for the trial as judged by clinical investigator. 2.Diagnosed of connective tissue disease-related interstitial lung disease(CTD-ILD), vasculitis-related interstitial lung disease, idiopathic pulmonary fibrosis (IPF). 3.Arterial partial pressure of oxygen (PaO2) <= 60 mmHg at screening (without oxygen supplement). 4.Lower respiratory tract infection within 1 month prior to and/or during screening. 5.Acute exacerbation of interstitial pneumonia with respiratory failure within 1 month prior to and/or during screening. 6.Uncontrolled active tuberculosis, infectious hepatitis B/C virus (HBV/HCV), HIV infection. 7.Started standard antifibrotic treatment (defined as pirfenidone 400-600 mg, t.i.d, for >=1 month; nintedanib 100-150 mg, b.i.d, for >=1 month); or antioxidant therapy (acetylcysteine 0.6 g, t.i.d, for >=1 month) within 1 month prior to screening. 8.Started standard immunosuppressive therapy (excluding glucocorticoids) including, but not limited to, cyclophosphamide, azathioprine, methotrexate, cyclosporine, tacrolimus, merti-macrolide, and tolizumab within 1 month prior to screening; rituximab within 6 months. 9.Have received (pathogenecity attenuated) live vaccine within 12 weeks prior to the first dose or plan to receive any (pathogenecity attenuated) live vaccine during the study period (except those who have received SARS-CoV-2 vaccine or vaccine booster for >=4 weeks). 10.The participant will be excluded with any disease condition or history as in followings: (1).the participant is unable to take the drug orally or has noticeable gastrointestinal absorption deficits; (2).have severe pulmonary hypertension (peak tricuspid regurgitation flow rate > 3.4 m/s on cardiac ultrasound), or extrapulmonary pathological abnormalities (e.g., chest wall deformities, large volume pleural effusions); (3).myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty(PTCA), coronary artery bypass grafting, heart failure (New York Heart Association Cardiac Function Class >II), transient ischemic attack (TIA), cerebral vascular infarction, cerebral hemorrhage, or subarachnoid hemorrhage in the 3 months prior to screening; (4).comorbidities such as the unstable cardiovascular disease (e.g., blood pressure failed to be controlled after 3 months of standard treatment for hypertension, systolic blood pressure(SBP) >=160 mmHg and/or diastolic blood pressure(DBP) >=100 mmHg); (5).participant with history of malignancy (except those who have achieved complete remission for five years prior to the screening of this study, who do not require any other treatment currently or during the following study period); (6).diagnosed cardiovascular, hepatic, renal, gastrointestinal, immune, endocrine, metabolic, psychiatric and/or psychological, neurological, and hematological and lymphatic systems prior to screening period, and not appropriate for the trial as judged by the clinical investigator; 11.The participant will be excluded with any abnormality of laboratory test of imaging as in followings: (1).blood cell count: hemoglobulin<90g/L, platelet <90 x 10^9/L,WBC<2.0 x 10^9/L; (2).liver function: AST or ALT or total bilirubin >1.5 times of upper limits of normal (ULN); (3).renal function: creatinine clearance < 60 mL/min or serum creatinine >= 1.5 times of the upper limit of normal [measured values, or values calculated by the Cockcroft-Gault formula (details in Appendix 1)]; (4).infectious disease: active hepatitis B virus (conduct HBV-DNA assay if HBsAg positive and those who will be excluded with HBV-DNA above the upper limit of the reference level), active hepatitis C (conduct HCV-RNA assay if HCV antibody positive and those who will be excluded with HCV-RNA above the upper limit of the reference level), human immunodeficiency virus (defined as anti-HIV-Ab positive), syphilis (defined as treponema pallidum-specific antibodies(TP-Ab) positive); (5).thyroid ultrasound findings of thyroid imaging reporting and data system (TI-RADS) > grade 3 (details in Appendix 6); 12.Women who are in pregnancy or breastfeeding, or who was positive in pregnancy test. 13.Who have been treated with any other investigational drugs within 3 months or 5 half-lives prior to screening, or who are participating in a clinical trial of any medical devices within 3 months prior to screening. 14.Participants of any other reasons that may make influence of the adherence, interpretation of the results, or increasing the risk of participants, as judged by clinical investigators.

研究实施时间：

Study execute time：

从 From 2024-12-27 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-05-22 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组1	样本量：	12
Group：	Treatment group 1	Sample size：	12
干预措施：	激素标准治疗+卟硒啉片（450mg）；每天给药2次（bid），口服给药，治疗直至达到退出标准或治疗满24周	干预措施代码：
Intervention：	SOC (corticosteroids) + Butaselen tablets (450mg); administered twice daily (b.i.d.), orally, until the withdrawal criteria are met or treatment is completed for 24 weeks.	Intervention code：

组别：	试验组3	样本量：	6
Group：	Treatment group 3	Sample size：	6
干预措施：	卟硒啉片（600mg）；每天给药2次（bid），口服给药，治疗直至达到退出标准或治疗满24周	干预措施代码：
Intervention：	Butaselen tablets (600mg); administered twice daily (b.i.d.), orally, until the withdrawal criteria are met or treatment is completed for 24 weeks.	Intervention code：

组别：	安慰剂组1	样本量：	12
Group：	Placebo group 1	Sample size：	12
干预措施：	激素标准治疗+安慰剂；每天给药2次（bid），口服给药，治疗直至达到退出标准或治疗满24周	干预措施代码：
Intervention：	SOC (corticosteroids) + Placebo; administered twice daily (b.i.d.), orally, until the withdrawal criteria are met or treatment is completed for 24 weeks.	Intervention code：

组别：	安慰剂组2	样本量：	6
Group：	Placebo group 2	Sample size：	6
干预措施：	安慰剂；每天给药2次（bid），口服给药，治疗直至达到退出标准或治疗满24周	干预措施代码：
Intervention：	Placebo; administered twice daily (b.i.d.), orally, until the withdrawal criteria are met or treatment is completed for 24 weeks.	Intervention code：

组别：	试验组2	样本量：	12
Group：	Treatment group 2	Sample size：	12
干预措施：	激素标准治疗+卟硒啉片（600mg）；每天给药2次（bid），口服给药，治疗直至达到退出标准或治疗满24周	干预措施代码：
Intervention：	SOC (corticosteroids) + Butaselen tablets (600mg); administered twice daily (b.i.d.), orally, until the withdrawal criteria are met or treatment is completed for 24 weeks.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	中日友好医院	单位级别：	三甲
Institution hospital：	China-Japan Friendship Hospital	Level of the institution：	Third class A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京大学第一医院	单位级别：	三甲
Institution hospital：	Peking University First Hospital	Level of the institution：	Third class A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京安贞医院	单位级别：	三甲
Institution hospital：	Beijing Anzhen Hospital, Capital Medical University	Level of the institution：	Third class A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京朝阳医院	单位级别：	三甲
Institution hospital：	Beijing Chao-yang Hospital, Capital Medical University	Level of the institution：	Third class A

国家：	中国	省(直辖市)：	湖北	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	武汉市中心医院	单位级别：	三甲
Institution hospital：	The Central Hospital of Wuhan	Level of the institution：	Third class A

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	南京大学医学院附属鼓楼医院	单位级别：	三甲
Institution hospital：	Affiliated Drum Tower Hospital, Medical School of Nanjing University	Level of the institution：	Third class A

测量指标：

Outcomes：

指标中文名：	不良事件	指标类型：	主要指标
Outcome：	Adverse event	Type：	Primary indicator
测量时间点：	W4/W12/W24	测量方法：	评价不良事件（AE）发生频率和严重程度
Measure time point of outcome：	W4/W12/W24	Measure method：	Evaluate the frequency and severity of adverse events (AE) Serious Adverse event

指标中文名：	严重不良事件	指标类型：	主要指标
Outcome：	Serious Adverse event	Type：	Primary indicator
测量时间点：	W4/W12/W24	测量方法：	评价严重不良事件（SAE）发生频率和严重程度。
Measure time point of outcome：	W4/W12/W24	Measure method：	Evaluate the frequency and severity of serious adverse events (SAEs)

指标中文名：	药物不良反应	指标类型：	主要指标
Outcome：	adverse drug reactions	Type：	Primary indicator
测量时间点：	W4/W12/W24	测量方法：	评价药物不良反应（ADR）发生频率和严重程度
Measure time point of outcome：	W4/W12/W24	Measure method：	Evaluate the frequency and severity of adverse drug reactions(ADR)

指标中文名：	每日口服激素的下降剂量（mg/天）	指标类型：	次要指标
Outcome：	Decreasing Dose of daily oral hormones (mg/ day)	Type：	Secondary indicator
测量时间点：	W24	测量方法：
Measure time point of outcome：	W24	Measure method：

指标中文名：	每日口服激素的下降百分比（%）	指标类型：	次要指标
Outcome：	Percentage reduction (%) in daily oral hormones	Type：	Secondary indicator
测量时间点：	W24	测量方法：
Measure time point of outcome：	W24	Measure method：

指标中文名：	达到目标维持剂量的时间	指标类型：	次要指标
Outcome：	Time to reach the target maintenance dose	Type：	Secondary indicator
测量时间点：	W24	测量方法：
Measure time point of outcome：	W24	Measure method：

指标中文名：	达到目标维持剂量并维持至24周的患者人数	指标类型：	次要指标
Outcome：	Number of patients who reached the target maintenance dose and were maintained through 24 weeks	Type：	Secondary indicator
测量时间点：	W24	测量方法：
Measure time point of outcome：	W24	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：

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	80	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）：

筛选合格的受试者，根据其是否接受激素治疗作为基础治疗进行分层，其中纳入36例以激素治疗作为基础治疗的纤维化性间质性肺病受试者，按照12:12:12随机接受激素标准治疗联合卟硒啉片450mg, 600mg或安慰剂；另外纳入12例不接受激素治疗作为基础治疗（包含受试者对激素不能耐受、受试者不愿接受激素治疗、激素治疗对受试者无效/副作用）的纤维化性间质性肺病受试者，按照6:6随机接受卟硒啉片600mg或安慰剂。卟硒啉片每天给药2次（bid），口服给药，治疗直至达到退出标准或治疗满24周（以先发生者为准）。

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

Eligible participants will be stratified based on whether they receive hormone therapy as background treatment. Among them, 36 participants with fibrotic interstitial lung disease receiving hormone therapy as background treatment will be enrolled and randomized in a 1:1:1 ratio to receive standard hormone therapy combined with Butaselen tablets 450mg, 600mg, or placebo (12 participants in each group). Additionally, 12 participants with fibrotic interstitial lung disease not receiving hormone therapy as background treatment (including those intolerant to hormone therapy, unwilling to receive hormone therapy, or for whom hormone therapy is ineffective/causes side effects) will be enrolled and randomized in a 1:1 ratio to receive Butaselen tablets 600mg or placebo (6 participants in each group). Butaselen tablets will be administered orally twice daily (bid) until reaching the withdrawal criteria or completing 24 weeks of treatment, whichever occurs first.

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：

拟用于开展药物基因组学、转录组学及代谢组学研究的生物样本分析单位的检测负责人处于非盲状态，分析人员处于盲态。样本到达检测单位后，检测单位分拣安慰剂组样本和试验组样本，检测人员对试验药物组样本进行药物基因组学、转录组学及代谢组学检测。其他生物标志物检测项目采取双盲检测。

Blinding：

The test leader of the biosample analysis unit for pharmacogenomics, transcriptomics, and metabolomics studies was unblinded, and the analyst was blinded. After the samples arrived at the testing unit, the testing unit sorted the samples of placebo group and experimental group, and the testing personnel conducted pharmacogenomics, transcriptomics and metabolomics tests on the samples of the experimental drug group. Other biomarker tests were double-blind.

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）：	预计时间：2026年12月31日；采用网络平台，名称为：药物临床试验登记与信息公示平台；网址为：www.chinadrugtrials.org.cn
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Estimated date: December 31, 2026;Using network platform, the name is: Drug clinical trial registration and information disclosure platform;website is: www.chinadrugtrials.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：	一病例记录表二电子采集和管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	1 Case Record Form(CRF) 2 Electronic Data Capture(EDC)
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-03-16 17:29:26