NCT07366866招募中1 期
A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of GenSci136 for Injection in Healthy Adult Participants in China.
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- ● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs)
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female, aged 18 to 45 years (both inclusive) at the time of signing informed consent form (ICF).
- •Male body weight ≥ 50 kg or female body weight ≥ 45 kg; BMI between 18-28 kg/m2 (both inclusive) at screening.
- •Males of reproductive age and females of childbearing potential must agree to take highly effective contraceptive methods from screening to the end of the study, and have no plans for conception, sperm donation, or egg donation; females of childbearing potential must have a negative pregnancy test at screening/baseline period and are not breastfeeding.
- •Able to understand the trial procedures, voluntarily participate in the trial, understand and voluntarily sign the ICF, be able to follow all the trial requirements and complete the study.
排除标准
- •Known hypersensitivity to GenSci136 or any of the excipients contained in the GenSci136 formulation, or history of serious hypersensitivity reactions to any drug, compound, food, or other substance, or an allergic constitution.
- •Presence of tattoo, sunburn, scar or any other factors that may interfere with the assessment of the injection site at the intended injection area.
- •A history or presence of other significant metabolic, dermatologic, hepatic, renal, hematologic, cardiovascular, gastrointestinal, psychoneurological, respiratory, and/or other major disease that, in the opinion of the investigator, would affect the evaluation of the study.
- •Any major surgery within 3 months before screening, plan to undergo elective surgery during the study period, or have a history of any surgery that may affect the absorption, distribution, metabolism or excretion of the IMP.
- •Positive result of alcohol breath test, or drug abuser, or use of soft drugs (such as marijuana) within 3 months prior to screening, or use of hard drugs (such as cocaine and ketamine) within 1 year prior to screening, or positive for drug screening [including but not limited to morphine, ketamine, dimethyldioxyamphetamine, methamphetamine, tetrahydrocannabinol, and cocaine].
- •Participants judged by the investigator to be ineligible for other reasons.
研究组 & 干预措施
GenSci136
Experimental
Single ascending doses of GenSci136 administered subcutaneously (SC).
干预措施: GenSci136 (Drug)
Placebo
Placebo Comparator
Administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs)
时间窗: Day1-Day113
次要结局
- Serum Concentration of free GenSci136/total GenSci136(Day1-Day113)
- Maximum serum concentration (Cmax)(Day1-Day113)
- Time to maximum serum concentration (Tmax)(Day1-Day113)
- Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)(Day1-Day113)
- Area under concentration-time from time zero to infinity (AUC0-inf)(Day1-Day113)
- Terminal elimination half-life (t1/2)(Day1-Day113)
- Clearance (CL/F)(Day1-Day113)
- Apparent volume of distribution (Vd/F)(Day1-Day113)
- ● Changes from baseline in free and total a proliferation inducing ligand (APRIL) levels; ● Changes from baseline in free and total B-cell activating factor (BAFF) levels.(Day1-Day113)
- Incidence and the time of anti-drug antibody (ADA) positive after GenSci136 administration.(Day1-Day113)
研究者
研究点 (1)
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