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：	ChiCTR2400094216
最近更新日期： Date of Last Refreshed on：	2024-12-18 17:09:23
注册时间： Date of Registration：	2024-12-18 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	BM219在健康受试者中单次、多次给药剂量递增的安全性、耐受性及药代动力学特征以及在新型冠状病毒感染者中的有效性和安全性：I/II期临床研究
Public title：	Safety, tolerability, and pharmacokinetic characteristics of single and multiple dose escalation of BM219 in healthy subjects, as well as its efficacy and safety in COVID-19 patients: Phase I/II clinical study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	BM219在健康受试者中单次、多次给药剂量递增的安全性、耐受性及药代动力学特征以及在新型冠状病毒感染者中的有效性和安全性：I/II期临床研究
Scientific title：	Safety, tolerability, and pharmacokinetic characteristics of single and multiple dose escalation of BM219 in healthy subjects, as well as its efficacy and safety in COVID-19 patients: Phase I/II clinical study
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：	于婷	研究负责人：	李昕
Applicant：	Ting Yu	Study leader：	Xin Li
申请注册联系人电话： Applicant telephone：	+86 158 6707 9872	研究负责人电话： Study leader's telephone：	+86 731 8517 1436
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：	tingyu@biomissile.com	研究负责人电子邮件： Study leader's E-mail：	920365846@qq.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)自由贸易试验区盛荣路367号2号楼6层	研究负责人通讯地址：	湖南省长沙市劳动西路176号
Applicant address：	6F, Building2, No. 367 Shengrong Road, Zhangjiang, Shanghai, China	Study leader's address：	No. 176, Laodong West Road, 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：	博奥明赛(安吉)生物制药有限公司
Applicant's institution：	Biomissile (Anji) Pharmaceuticals Co., Ltd
研究负责人所在单位：	长沙市第三医院
Affiliation of the Leader：	The Third Hospital of Changsha

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：	CS3-2022EC-081; CS3 - (修)快 2023EC-027; CS3 - (修)快 2023EC-033; CS3 - (修)快 2023EC-036; CS3 - (修)快 2023EC-038	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：	长沙市第三医院伦理委员会
Name of the ethic committee：	Ethics Committee of Changsha Third Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2022-12-30 00:00:00
伦理委员会联系人：	廖彩秀
Contact Name of the ethic committee：	Caixiu Liao
伦理委员会联系地址：	中国湖南省长沙市天心区劳动西路176号
Contact Address of the ethic committee：	No. 176, Laodong West Road, Tianxin District, Changsha City, Hunan Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 731 8517 1341	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：

长沙市第三医院

Primary sponsor：

The Third Hospital of Changsha

研究实施负责（组长）单位地址：

湖南省长沙市劳动西路176号

Primary sponsor's address：

No. 176, Laodong West Road, 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)：	浙江	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	博奥明赛（安吉）生物制药有限公司	具体地址：	浙江省湖州市安吉县递铺街道半岛中路198号2幢1层42号
Institution hospital：	Biomissile (Anji) Pharmaceuticals Co., Ltd	Address：	Floor 1, Unit 42, Building 2, No. 198, Bandao Middle Road, Dipu Street, Anji County, Huzhou City, Zhejiang Province

经费或物资来源：

申办方

Source(s) of funding：

Sponsor

研究疾病：

新型冠状病毒感染

Target disease：

Corona Virus Disease 2019

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+II期

Study phase：

1-2

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

(1) Ia期：评估健康受试者单次雾化吸入BM219的安全性及耐受性。 (2) Ib期：评估健康受试者多次雾化吸入BM219的安全性及耐受性。 (3) II期：以安慰剂为对照，初步评估雾化吸入BM219的疗效，探索最佳给药剂量。

Objectives of Study：

(1) Phase Ia: To assess the safety and tolerability of a single nebulized inhalation of BM219 in healthy subjects. (2) Phase Ib: To assess the safety and tolerability of multiple nebulized inhalations of BM219 in healthy subjects. (3) Phase II: To evaluate the efficacy of nebulized inhalation of BM219, with placebo as a control, and to explore the optimal dosing regimen.

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

Healthy subjects:
(1) Chinese volunteers aged 18 years or older (inclusive), both male and female.
(2) Male volunteers weighing no less than 50 kg, and female volunteers weighing no less than 45 kg; Body Mass Index (BMI) within the range of 19 to 28 (inclusive of the boundary values). BMI = weight (kg) / height² (m²).
(3) Volunteers must sign an informed consent form before the trial and fully understand the trial content, procedures, and potential adverse reactions.
(4) Volunteers must be able to communicate well with the researchers and understand and comply with all requirements of this study.
People infected with novel coronavirus:
(1) Age >= 18 years old and <= 70 years old;
(2) Gender: Male or Female;
(3) Evidence of SARS-CoV-2 infection with clear laboratory records during the screening period: molecular testing (antigen or nucleic acid) of any respiratory specimen (such as oropharyngeal, nasal swab, or saliva) to determine infection;
(4) Diagnosed as asymptomatic carrier of SARS-CoV-2, mild or common type of novel coronavirus pneumonia;
(5) For asymptomatic carriers, the time from diagnosis to screening should be <= 5 days; For symptomatic patients, the time from symptom onset to screening should be <= 5 days. The symptoms of COVID-19 include fever, cough, nasal congestion or runny nose, sore or dry throat, shortness of breath or difficulty breathing, headache, muscle or body aches, diarrhea, chills, nausea, vomiting, etc.
(6) The subjects agree not to participate in other clinical trials during the study period;
(7) The subject promises to have no plans to conceive, donate sperm or eggs during the trial period and within 3 months after the last medication, and voluntarily adopt effective physical contraception measures (including partners);
(8) Be able to understand the research procedures, potential benefits, and potential risks, and voluntarily participate in the research; Able to communicate well with researchers, comply with the requirements of the entire study, and have signed a written informed consent form.

排除标准：

健康受试者: (1) 使用试验用药品前3个月内使用其他临床试验药物或器械，或计划在本研究期间参加其他药物或器械临床试验者； (2) 有呼吸系统病史，如慢性阻塞性肺病急性加重、肺纤维化、肺动脉高压、肺水肿、肺间质病变、支气管哮喘、矛盾性支气管痉挛、或咽喉溃疡、水肿，或既往进行过咽喉、气管/支气管及肺部手术，或使用研究药物前4周内，出现病毒或细菌引起的上、下呼吸道感染，急性鼻窦炎等病史且研究者认为有临床意义者； (3) 有心血管系统、消化系统、内分泌系统、泌尿系统、神经系统、血液学、免疫学（包括个人或家族史遗传性免疫缺陷）、代谢异常等病史且研究者认为目前仍有临床意义者； (4) 有药物过敏史，或特定过敏史者（哮喘、荨麻疹、湿疹等），或过敏体质者（如对两种或以上药物、食物和花粉过敏）或已知对本药组分或类似物过敏者。 (5) 不能耐受静脉穿剌或有晕血、晕针史者； (6) 使用研究药物前6个月内接受过经研究者判断会影响药物吸收、分布、代谢、排泄的手术者；或使用研究药物前4周内接受过外科手术；或计划在试验期间进行外科手术者； (7) 使用研究药物前14天内使用过任何药物者（包括中草药、保健品等） (8) 使用研究药物前30天内使用过任何影响研究药物吸收代谢，或与研究药物有相互作用的药物，经研究者判断不宜参加试验者； (9) 使用研究药物前14天内接种疫苗或减毒活疫苗，或计划会在试验期间接种疫苗者； (10) 使用研究药物前3个月内献血或大量失血（＞400mL）者，接受输血或使用血制品者，或打算在试验期间或试验结束后3个月内献血或血液成份者； (11) 药物滥用者或使用研究药物前1年内使用过软毒品（如：大麻）或硬毒品（如：可卡因、苯环己哌啶等）者； (12) 吸烟者，或试验期间不能停止使用任何烟草类产品； (13) 酗酒者或使用研究药物前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）；或试验期间不愿意停止饮酒或任何含酒精的制品； (14) 每天饮用过量茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250 mL）者，或不同意试验期间停止饮用茶、咖啡和/或含咖啡因的饮料者； (15) 使用研究药物前7天内进食可能影响药物体内代谢的饮食（包括葡萄柚或葡萄柚产品、火龙果、芒果、柚子、橘子等），或研究者认为有其他影响药物吸收、分布、代谢、排泄的饮食者，或不同意试验期间停止进食上述饮食者； (16) 对饮食有特殊要求，不能遵守统一饮食者； (17) 志愿者（或其伴侣）试验期间至试验结束后6个月内有妊娠计划、捐精捐卵计划，或不愿采取一种或一种以上的非药物避孕措施（如完全禁欲、避孕套、避孕环、伴侣结扎等）者； (18) 女性志愿者为妊娠或哺乳期女性；或在使用研究药物前2周内发生非保护性性行为者；或使用研究药物前30天内使用口服避孕药或使用研究药物前6个月内使用长效雌激素或孕激素注射剂或埋植片者； (19) 体格检查、心电图、生命体征、胸部X线、肺功能、实验室检查各项检查异常有临床意义者（以临床医师判断为准）； (20) 肺功能检查：FEV1实测值/FEV1预计值≤80%或FVC≤预计值的80%者； (21) 新型冠状病毒核酸检测为阳性； (22) 烟检结果阳性者； (23) 尿毒筛试验阳性者； (24) 酒精呼气试验阳性者； (25) 不能正确的使用气雾剂装置或吸入剂给药培训不合格者； (26) 志愿者可能因为其他原因而不能完成本研究或经研究者判断具有其它不宜参加试验原因者。新型冠状病毒感染者： (1) 既往已经感染过新型冠状病毒（SARS-CoV-2）的患者； (2) 筛选前 14 天内使用过 SARS-CoV-2 抗病毒药物；或已接受（随机前 30 天内或 5 个药物半衰期内，以较长者为准）或研究期间预期接受 SARS-CoV-2 单克隆抗体或恢复期 COVID-19 患者血浆治疗； (3) 重型或危重型新型冠状肺炎患者，符合以下任意一条： a. 出现气促，RR≥30 次/分； b. 静息状态下，呼吸空气时，氧饱和度≤93%； c. 临床症状进行性加重，肺部影像学显示 24-48 小时内病灶明显进展＞50%者； d. 出现呼吸衰竭，且需要机械通气； e. 出现休克； f. 合并其他器官功能衰竭等。 (4) 筛选时有除 COVID-19 以外的疑似或确诊的急性全身性感染（例如病原学检查提示合并流感；根据症状、体征、实验室检查或影像学提示有细菌感染的高度可能性），可能会干扰对研究干预反应的评估； (5) 免疫功能缺陷（如艾滋病患者，长期使用皮质类固醇或其他免疫抑制药物）； (6) 以前对任何抗体药物过敏，或已知对试验药物或安慰剂的成分过敏； (7) 筛选前 3 个月内接种过新冠疫苗或者计划在试验期间接种新冠疫苗的患者； (8) 活动性病理性出血史者（如消化性溃疡、颅内出血等），或有出血倾向者（如凝血功能障碍、反复牙龈出血等）； (9) 筛选期实验室检查符合以下情况的： a. 丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)或 γ-谷氨酰转移酶(GGT)≥2.5×ULN，总胆红素≥1.5ULN； b. 肾小球过滤率[eGFR]< 45 mL/min/1.73 m（2 [CKD-EPI]公式计算）； c. 空腹血糖＞11.1 mmol/L； d. 血红蛋白（Hb）< 8.0 g/dL； e. 以下任何一项：血小板(PLT)< 50×109/L；中性粒细胞绝对计数< 1.0×109/L。 (10)试验筛选期的 HIV 检查初筛呈阳性者、梅毒螺旋体抗体呈阳性者；已知患有活动性肝病(如急性或慢性乙肝、丙肝、PBC、肝硬化或急性肝衰竭，非酒精性脂肪肝除外)。 (11)试验筛选前 3 个月内重大外伤或接受过重大手术者，或未从手术中康复，或接受了可能显著影响研究药物体内过程或安全性评价的手术者，或预计在试验过程中有手术计划者； (12)筛选前 90 天内使用其他临床试验药物或器械，或计划在本研究期间参加其他药物或器械临床试验者； (13)妊娠期或哺乳期女性或妊娠试验呈阳性者； (14)有晕针晕血史者，或不适合进行静脉采血者； (15)研究者认为受试者具有任何不宜参加此试验的其它因素：如其他严重疾病（包括精神疾病）、实验室检查严重异常、家庭或社会因素，可能影响受试者的安全或血样收集。

Exclusion criteria：

Healthy subjects: (1) Subjects who have used other clinical trial medications or devices within 3 months prior to the use of the investigational product, or plan to participate in other clinical trials of medications or devices during this study. (2) Subjects with a history of respiratory diseases such as acute exacerbations of chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, interstitial lung disease, bronchial asthma, paradoxical bronchospasm, or throat ulcers, edema, or who have undergone throat, tracheal/bronchial, and lung surgeries in the past, or who have had viral or bacterial upper and lower respiratory tract infections, acute sinusitis, etc., within 4 weeks before using the investigational drug and the investigator considers it clinically significant. (3) Subjects with a history of cardiovascular, digestive, endocrine, urinary, neurological, hematological, immunological (including personal or familial history of inherited immunodeficiency), or metabolic abnormalities that the investigator considers clinically significant at present. (4) Subjects with a history of drug allergies, or specific allergies (such as asthma, urticaria, eczema, etc.), or who are allergic constitution (such as allergy to two or more drugs, foods, and pollens) or are known to be allergic to the components or analogs of the investigational drug. (5) Subjects who are intolerant to venipuncture or have a history of vasovagal syncope. (6) Subjects who have undergone surgeries within 6 months prior to using the investigational drug that the investigator believes will affect drug absorption, distribution, metabolism, or excretion; or who have undergone surgery within 4 weeks before using the investigational drug; or who plan to undergo surgery during the trial. (7) Subjects who have used any medications (including Chinese herbal medicines, health supplements, etc.) within 14 days before using the investigational drug. (8) Subjects who have used any medications within 30 days before using the investigational drug that affect the absorption and metabolism of the investigational drug or interact with it, and the investigator determines them unsuitable for participation in the trial. (9) Subjects who have received vaccinations or live attenuated vaccines within 14 days before using the investigational drug, or plan to receive vaccinations during the trial. (10) Subjects who have donated blood or experienced significant blood loss (>400mL) within 3 months before using the investigational drug, received blood transfusions or blood products, or plan to donate blood or blood components during the trial or within 3 months after the trial. (11) Subjects with drug abuse or who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before using the investigational drug. (12) Smokers or subjects who cannot stop using any tobacco products during the trial. (13) Subjects with alcohol abuse or who have frequently consumed alcohol within 6 months before using the investigational drug, defined as consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); or who are unwilling to stop consuming alcohol or any alcohol-containing products during the trial. (14) Subjects who consume excessive amounts of tea, coffee, and/or caffeine-containing beverages daily (more than 8 cups, with 1 cup = 250 mL), or who disagree to stop consuming tea, coffee, and/or caffeine-containing beverages during the trial. (15) Subjects who have consumed diets within 7 days before using the investigational drug that may affect drug metabolism in the body (including grapefruit or grapefruit products, pitaya, mango, pomelo, oranges, etc.), or who have diets that the investigator believes may affect drug absorption, distribution, metabolism, or excretion, or who disagree to stop consuming the aforementioned diets during the trial. (16) Subjects with special dietary requirements that cannot comply with a unified diet. (17) Volunteers (or their partners) who have plans for pregnancy, donation of sperm or eggs during the trial period until 6 months after the end of the trial, or who are unwilling to adopt one or more non-pharmacological contraceptive methods (such as complete abstinence, condoms, contraceptive rings, partner sterilization, etc.). (18) Female volunteers who are pregnant or lactating; or who have had unprotected sexual intercourse within 2 weeks before using the investigational drug; or who have used oral contraceptives within 30 days before using the investigational drug or used long-acting estrogen or progesterone injections or implants within 6 months before using the investigational drug. (19) Subjects with clinically significant abnormalities in physical examination, electrocardiogram, vital signs, chest X-ray, lung function, and laboratory tests (as determined by the clinician). (20) Lung function test: Subjects with an actual FEV1/predicted FEV1 ≤ 80% or FVC ≤ 80% of the predicted value. (21) Subjects with a positive result for nucleic acid testing for SARS-CoV-2. (22) Subjects with a positive result for nicotine testing. (23) Subjects with a positive result for urine drug screening. (24) Subjects with a positive result for alcohol breath testing. (25) Subjects who cannot correctly use the aerosol device or who fail the training for inhaler administration. (26) Subjects who may not complete the study due to other reasons or who have other reasons deemed unsuitable for participation in the trial by the investigator. People infected with novel coronavirus: (1) Patients who have been infected with novel coronavirus (SARS-CoV-2) in the past; (2) Used SARS-CoV-2 antiviral drugs within 14 days prior to screening; Or have received (within the first 30 days of randomization or within 5 drug half lives, whichever is longer) or expected to receive SARS-CoV-2 monoclonal antibody or convalescent COVID-19 patient plasma treatment during the study period; (3) Patients with severe or critical COVID-19 who meet any of the following criteria: a. Shortness of breath, RR >= 30 times/minute; b. At rest, when breathing air, the oxygen saturation is <= 93%; c. Patients with progressive worsening of clinical symptoms and significant progression of lesions>50% within 24-48 hours as shown by pulmonary imaging; d. Respiratory failure occurs and mechanical ventilation is required; e. Experiencing shock; f. Merge other organ failure, etc. (4) Suspected or confirmed acute systemic infections other than COVID-19 during screening (such as pathogen examination suggesting influenza; high likelihood of bacterial infection based on symptoms, signs, laboratory tests, or imaging findings) may interfere with the evaluation of research intervention response; (5) Immune function defect (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs); (6) Previously allergic to any antibody drug, or known to be allergic to the components of the test drug or placebo; (7) Patients who have been vaccinated with COVID-19 vaccine within 3 months before screening or who plan to be vaccinated with COVID-19 vaccine during the trial period; (8) Individuals with a history of active pathological bleeding (such as peptic ulcers, intracranial hemorrhage, etc.), or those with a tendency to bleed (such as coagulation dysfunction, recurrent gum bleeding, etc.); (9) During the screening period, laboratory tests meet the following criteria: a. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or gamma glutamyl transferase (GGT) >= 2.5 × ULN, total bilirubin >= 1.5 ULN; b. Glomerular filtration rate [eGFR]<45 mL/min/1.73 m (calculated using the 2 [CKD-EPI] formula); c. Fasting blood glucose>11.1 mmol/L; d. Hemoglobin (Hb)<8.0 g/dL; e. Any of the following: Platelet count (PLT)<50 × 10^9/L; The absolute count of neutrophils is less than 1.0 × 10^9/L. (10) Individuals who tested positive for HIV during the screening period and tested positive for Treponema pallidum antibodies; Known to have active liver disease (such as acute or chronic hepatitis B, hepatitis C, PBC, cirrhosis or acute liver failure, except nonalcoholic fatty liver). (11) Individuals who have suffered significant trauma or undergone major surgery within the past 3 months prior to the trial screening, or have not recovered from surgery, or have undergone surgery that may significantly affect the in vivo process or safety evaluation of the investigational drug, or are expected to have a surgical plan during the trial process; (12) Individuals who have used other clinical trial drugs or devices within 90 days prior to screening, or plan to participate in clinical trials of other drugs or devices during the study period; (13) Pregnant or lactating women or those who test positive for pregnancy; (14) Individuals with a history of needle and blood dizziness, or those who are not suitable for intravenous blood collection; (15) The researchers believe that the subjects have any other factors that are not suitable for participating in this trial, such as other serious illnesses (including mental illness), serious abnormalities in laboratory tests, family or social factors, which may affect the safety of the subjects or the collection of blood samples.

研究实施时间：

Study execute time：

从 From 2023-06-05 00:00:00至 To 2023-08-19 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-06-05 00:00:00 至 To 2023-08-19 00:00:00

干预措施：

Interventions：

组别：	A组	样本量：	8
Group：	A group	Sample size：	8
干预措施：	受试者雾化吸入试验用药物60 mg（BM219 或者安慰剂）	干预措施代码：
Intervention：	Subjects undergo nebulization inhalation of investigational drugs 60 mg (BM219 or placebo)	Intervention code：

组别：	B组	样本量：	8
Group：	B group	Sample size：	8
干预措施：	受试者雾化吸入试验用药物120 mg（BM219 或者安慰剂）	干预措施代码：
Intervention：	Subjects undergo nebulization inhalation of investigational drugs 120 mg (BM219 or placebo)	Intervention code：

组别：	C组	样本量：	8
Group：	C group	Sample size：	8
干预措施：	受试者雾化吸入试验用药物120 mg（BM219 或者安慰剂）	干预措施代码：
Intervention：	Subjects undergo nebulization inhalation of investigational drugs 120 mg (BM219 or placebo)	Intervention code：

组别：	D组	样本量：	8
Group：	D group	Sample size：	8
干预措施：	受试者雾化吸入试验用药物180 mg（BM219 或者安慰剂）	干预措施代码：
Intervention：	Subjects undergo nebulization inhalation of investigational drugs 180 mg (BM219 or placebo)	Intervention code：

组别：	E组	样本量：	8
Group：	E group	Sample size：	8
干预措施：	受试者雾化吸入试验用药物120 mg，QD（BM219 或者安慰剂）	干预措施代码：
Intervention：	Subjects undergo nebulization inhalation of investigational drugs 120 mg, QD (BM219 or placebo)	Intervention code：

组别：	F组	样本量：	8
Group：	F group	Sample size：	8
干预措施：	受试者雾化吸入试验用药物120 mg，BID（BM219 或者安慰剂）	干预措施代码：
Intervention：	Subjects undergo nebulization inhalation of investigational drugs 120 mg, BID (BM219 or placebo)	Intervention code：

组别：	G组	样本量：	8
Group：	G group	Sample size：	8
干预措施：	受试者雾化吸入试验用药物180 mg，QD（BM219 或者安慰剂）	干预措施代码：
Intervention：	Subjects undergo nebulization inhalation of investigational drugs 180 mg, QD (BM219 or placebo)	Intervention code：

组别：	试验组1	样本量：	20
Group：	experimental group 1	Sample size：	20
干预措施：	BM219，120 mg BID	干预措施代码：
Intervention：	BM219, 120 mg BID	Intervention code：

组别：	试验组2	样本量：	20
Group：	experimental group 2	Sample size：	20
干预措施：	BM219，60 mg QD	干预措施代码：
Intervention：	BM219, 60 mg QD	Intervention code：

组别：	试验组3	样本量：	20
Group：	experimental group 3	Sample size：	20
干预措施：	BM219，120 mg QD	干预措施代码：
Intervention：	BM219, 120 mg QD	Intervention code：

组别：	对照组	样本量：	24
Group：	control group	Sample size：	24
干预措施：	安慰剂	干预措施代码：
Intervention：	placebo	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：	Hunan	City：
单位(医院)：	长沙市第三医院	单位级别：	三甲
Institution hospital：	The Third Hospital of Changsha	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	安全性：临床研究期间发生的任何不良事件	指标类型：	主要指标
Outcome：	Safety: Any adverse events that occur during clinical research	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血清中BM219的浓度经时变化	指标类型：	次要指标
Outcome：	Changes over time in serum concentrations of BM219	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药代动力学参数	指标类型：	次要指标
Outcome：	Pharmacokinetic (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：	评估Cmax、AUC和给药剂量的线性关系	指标类型：	次要指标
Outcome：	Evaluation of the linear relationship between Cmax, AUC, and administered dose	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Ia期：比较两种雾化器雾化后的PK参数	指标类型：	次要指标
Outcome：	Phase Ia: Comparison of PK parameters after atomization using two different nebulizers	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	诱导痰液中BM219浓度经时变化	指标类型：	次要指标
Outcome：	Changes over time in BM219 concentrations in induced sputum	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	对ADA产生的时间、滴度等进行分析	指标类型：	次要指标
Outcome：	Analysis of the time of onset and titer of anti-drug antibodies (ADA)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	各个时间点咽拭子中病毒载量较基线的变化	指标类型：	主要指标
Outcome：	Changes in viral load in throat swabs at different time points compared to baseline	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	各时间点病毒载量低于检测限以下的受试者比例	指标类型：	次要指标
Outcome：	Proportion of subjects with viral load below the detection limit at each time point	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	首次给药至首次核酸转阴的时间	指标类型：	次要指标
Outcome：	The time from the first administration to the first negative nucleic acid test result	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	首次出现症状至首次核酸转阴的时间	指标类型：	次要指标
Outcome：	The time from the first appearance of symptoms to the first negative nucleic acid test result	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	至持续临床恢复的时间	指标类型：	次要指标
Outcome：	Time to sustained clinical recovery	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	新型冠状肺炎进展至重型或危重型肺炎率或死亡率	指标类型：	次要指标
Outcome：	Progression rate or mortality rate of novel coronavirus pneumonia to severe or critical pneumonia	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：	痰液	组织：
Sample Name：	Sputum	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	70	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）：

独立于研究团队的随机统计师采用SAS 9.4或以上版本的PROC PLAN过程产生随机序列

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

A random statistician independent of the research team generated random sequences using SAS 9.4 or higher version of the PROC PLAN process

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
Blinding：	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）：	发表文章后；邮件联系
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After publishing the paper; Contact by email
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、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：	Case Record Form and Electronic Data Capture
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-12-18 17:08:02