NCT07528053尚未招募1 期
A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants
Shanghai Argo Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年4月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Primary Endpoints
研究概览
简要总结
A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants
详细描述
A Phase 1, Open-Label, Single Dose Bridging Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20805-2 in Healthy Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have given written informed consent and be able to comply with all study requirements
- •Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
- •Body mass index (BMI) ≥18 and ≤32 kg/m2 and body weight ≥50 kg Female participants must be non-pregnant
- •Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 48 weeks following administration of the study drug
排除标准
- •Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that
- •Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site
- •Hospitalization for any reason within 60 days prior to screening.
- •Presence of carcinoma and history of carcinoma
- •Any clinically significant acute condition
- •Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after at least 5 minutes resting
- •Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening
- •Participants with ANY in clinical laboratory tests at screening or Day-
- •History of bleeding diathesis or clinically significant hemorrhagic disorders Positive for hepatitis B surface antigen
- •Single 12-lead ECG with clinically significant abnormalities at screening or Day -1
- •Use of an investigation agent or device within 30 days or 5 half-lives (whichever is longer) before the study drug administration.
- •Used prescription drugs, excluding hormonal contraceptives
- •Used over-the-counter (OTC) medications
- •Have received treatment with small interfering RNA (siRNA) within the last 12 months
- •History of allergic reactions to synthetic siRNA or GalNAc and/or any other clinically significant allergic reactions.
- •Use of more than 10 tobacco/nicotine containing products or equivalent per day within 30 days prior to screening and not willing to abstain for 48 hours prior to admission to the unit
- •History or clinical evidence of alcohol substance abuse, within the 12 months before screening
- •History or clinical evidence of drug abuse, within the 12 months before screening
- •Positive test for alcohol or drugs of abuse at screening or Day -1
- •Have received vaccination with a live vaccine
- •Donated or lost >200 mL of blood or plasma within 30 days prior to screening
- •Any conditions which, in the opinion of the Investigator
研究组 & 干预措施
Cohort 3
Experimental
BW-20805-2 (cohort 3, n=8)
干预措施: BW-20805-2 (Drug)
Cohort 1
Experimental
BW-20805 (cohort 1, n=8)
干预措施: BW-20805 (Drug)
Cohort 2
Experimental
BW-20805 (cohort 2, n=8)
干预措施: BW-20805 (Drug)
结局指标
主要结局
Primary Endpoints
时间窗: week 48
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
次要结局
- Secondary Endpoints(week 48)
研究者
研究点 (1)
Loading locations...
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