A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, PK, PD and Immunogenicity of Single Subcutaneous Administered SHR-1703 in Healthy Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 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 pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.
详细描述
The study will consist of one dose esclation part with a total of 3 dose levels. The Subjects will be randomized to receive SHR-1703 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
- •Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;
- •Body weight ≥45 kg (Both male and female), body mass index (BMI) between ≥19.0 and ≤29.9 kg/m2, inclusive;
- •No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.
- •Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 30-days after last scheduled follow-up visit.
排除标准
- •Known history or suspected of being allergic to the study drug.
- •Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
- •Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer
- •Use of any medicine within 4-weeks prior to the IP administration
- •Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.
- •Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated
- •Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial
- •Patients with known or suspected parasitic infection within 6 months before screening
- •Either ALT, AST, ALP, GGT or total bilirubin level exceeds upper limit of normal range (ULN) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment)
- •More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.
- •History of alcohol abuse within 3 months prior to the IP administration
研究组 & 干预措施
SHR-1703 Dose Level 1
Dose level 1 SHR-1703
干预措施: SHR-1703 (Drug)
SHR-1703 Dose Level 1
Dose level 1 SHR-1703
干预措施: Placebo (Drug)
SHR-1703 Dose Level 2
Dose level 2 SHR-1703
干预措施: SHR-1703 (Drug)
SHR-1703 Dose Level 2
Dose level 2 SHR-1703
干预措施: Placebo (Drug)
SHR-1703 Dose Level 3
Dose level 3 SHR-1703
干预措施: SHR-1703 (Drug)
SHR-1703 Dose Level 3
Dose level 3 SHR-1703
干预措施: Placebo (Drug)
SHR-1703 Dose Level 4 (optional)
Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review
干预措施: SHR-1703 (Drug)
SHR-1703 Dose Level 4 (optional)
Dose level 4 SHR-1703 Additional dose escalations, as determined by the SMC depend on PK and safety data review
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 34 weeks)
Incidence and severity of adverse events
次要结局
- Pharmacokinetics-AUC0-last(Start of Treatment to end of study (approximately 34 weeks))
- Pharmacokinetics-Tmax(Start of Treatment to end of study (approximately 34 weeks))
- Pharmacokinetics-Cmax(Start of Treatment to end of study (approximately 34 weeks))
- Pharmacokinetics-CL/F(Start of Treatment to end of study (approximately 34 weeks))
- Pharmacokinetics-Vz/F(Start of Treatment to end of study (approximately 34 weeks))
- Pharmacodynamics-Eosinophils(Start of Treatment to end of study (approximately 34 weeks))
- Anti-drug-antibody(Start of Treatment to week 22 after IP administration)
- Pharmacokinetics-AUC0-inf(Start of Treatment to end of study (approximately 34 weeks))
- Pharmacokinetics-t1/2(Start of Treatment to end of study (approximately 34 weeks))