A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Subcutaneous/Intravenous Administered SHR-1139 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PK profile of SHR-1139 after a single administration:
研究概览
简要总结
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy white participants.
- •Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- •Male aged between 18 to 55 years of age (inclusive)
- •Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
- •Men and WOCBP must agree to take highly effective contraceptive methods
排除标准
- •History or evidence of clinically significant disorders.
- •Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or any component of it.
- •Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, or in the follow-up period of a clinical study, whichever is longer (according to the date of the signed consent form) prior to screening.
- •Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
- •Positive pregnancy test at screening or D-1/check-in.
- •Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
SHR-1139 dose level 1
Single dose of SHR-1139 given subcutaneously (dose level 1)
干预措施: SHR-1139 Injection (Drug)
SHR-1139 dose level 2
Single dose of SHR-1139 given subcutaneously (dose level 2)
干预措施: SHR-1139 Injection (Drug)
SHR-1139 dose level 3
Single dose of SHR-1139 given intravenously (dose level 3)
干预措施: SHR-1139 Injection (Drug)
结局指标
主要结局
PK profile of SHR-1139 after a single administration:
时间窗: Start of Treatment to end of study (Day 253)
Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax )
Immunogenicity profile of SHR-1139 after a single dose administration
时间窗: Day 253
The number of participants with anti-drug antibody (ADA)
PK profile of SHR-1139 after a single administration
时间窗: Start of Treatment to end of study (Day 253)
Pharmacokinetics- Area under the concentration-time curve from time 0 to last time point after SHR-1139 administration (AUC0-last)
PK profile of SHR-1139 after a single administration
时间窗: From time 0 to infinity after SHR-1139 administration (Day 253)
Pharmacokinetics- Area under the concentration-time curve (AUC0-inf)
次要结局
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events(Day 295)