A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Subcutaneous Administered SHR-1905 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.
详细描述
The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.
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
- Double (Participant, Investigator)
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
- •Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
- •Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- •Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
- •For healthy subjects, no clinically significant abnormalities.
- •Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
排除标准
- •Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- •Severe injuries or major surgeries within 6 months before screening.
- •Subjects with infecious disease.
- •Hyper/Hypotension at screening and at check in.
- •Clinically significant abnormalities in 12-Lead ECG
- •More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
- •Positive urine drug screen .
- •Subject who cannot perform venous blood sampling.
- •Known history or suspected of being allergic to the study drugs and their excipients.
- •Use of any medicine within 4-weeks or within 5 half-lives
- •History of alcohol abuse within 3 months prior to the IP administration .
- •Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
- •in the investigator's judgment, may increase the risk to the subject
研究组 & 干预措施
SHR-1905 Dose Level 1
SHR-1905 Dose level 1
干预措施: SHR-1905 (Drug)
SHR-1905 Dose Level 1
SHR-1905 Dose level 1
干预措施: Placebo (Drug)
SHR-1905 Dose Level 2
SHR-1905 Dose level 2
干预措施: SHR-1905 (Drug)
SHR-1905 Dose Level 2
SHR-1905 Dose level 2
干预措施: Placebo (Drug)
SHR-1905 Dose Level 3
SHR-1905 Dose level 3
干预措施: SHR-1905 (Drug)
SHR-1905 Dose Level 3
SHR-1905 Dose level 3
干预措施: Placebo (Drug)
SHR-1905 Dose Level 4
SHR-1905 Dose level 4
干预措施: SHR-1905 (Drug)
SHR-1905 Dose Level 4
SHR-1905 Dose level 4
干预措施: Placebo (Drug)
SHR-1905 Dose Level 5
SHR-1905 Dose level 5
干预措施: SHR-1905 (Drug)
SHR-1905 Dose Level 5
SHR-1905 Dose level 5
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: Start of Treatment to end of study (approximately 16 weeks)
Incidence and severity of adverse events
次要结局
- Pharmacokinetics-AUC0-last(Start of Treatment to end of study (approximately 16 weeks))
- Pharmacokinetics-Tmax(Start of Treatment to end of study (approximately 16 weeks))
- Pharmacokinetics-CL/F(Start of Treatment to end of study (approximately 16 weeks))
- Pharmacokinetics-Cmax(Start of Treatment to end of study (approximately 16 weeks))
- Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 16 weeks))
- Pharmacokinetics-Vz/F(Start of Treatment to end of study (approximately 16 weeks))
- Pharmacokinetics-t1/2(Start of Treatment to end of study (approximately 16 weeks))
- Anti-Drug antibody(Start of Treatment to end of study (approximately 16 weeks))