A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult 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
- Number of participants with Adverse Events
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
详细描述
Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 follow randomized, double-blinded, placebo-control design. Blood samples will be collected for PK, immunogenicity, biomarkers, laboratory tests, etc. according to the study schedule throughout the study.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand protocol requirements and sign a written ICF.
- •Male or female subjects aged 18-45 years when signing the ICF.
- •Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m
- •Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.
- •Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.
排除标准
- •History of severe allergy, or with a history of allergy to the study treatment or related excipients.
- •With any clinically significant diseases prior to the screening visit.
- •Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
- •History of of significant alcohol abuse.
- •History of significant drug abuse.
- •Subjects who have positive result for urine nicotine test at screening.
- •Pregnant, or nursing females.
研究组 & 干预措施
626 Group S1 for subcutaneous injection
dose level 1 of 626
干预措施: 626 (Drug)
626 Group S2 for subcutaneous injection
dose level 2 of 626
干预措施: 626 (Drug)
626 Group S3 for subcutaneous injection
dose level 3 of 626
干预措施: 626 (Drug)
626 Group S4 for subcutaneous injection
dose level 4 of 626
干预措施: 626 (Drug)
626 Group S5 for subcutaneous injection
dose level 5 of 626
干预措施: 626 (Drug)
626 Group S6 for subcutaneous injection
dose level 6 of 626
干预措施: 626 (Drug)
626 Group S4 for subcutaneous injection
dose level 4 of 626
干预措施: Placebo (Drug)
626 Group S5 for subcutaneous injection
dose level 5 of 626
干预措施: Placebo (Drug)
626 Group S6 for subcutaneous injection
dose level 6 of 626
干预措施: Placebo (Drug)
626 Group S1 for subcutaneous injection
dose level 1 of 626
干预措施: Placebo (Drug)
626 Group S2 for subcutaneous injection
dose level 2 of 626
干预措施: Placebo (Drug)
626 Group S3 for subcutaneous injection
dose level 3 of 626
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Adverse Events
时间窗: 90 days
Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
次要结局
- Cmax(90 days)
- Tmax(90 days)
- AUC0-last(90 days)
- Incidence of Anti-Drug Antibody(90 days)