A Randomized, Double-blind, Placebo-controlled, Mutiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IBI3033 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)/serious adverse events (SAEs)
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3033 in Chinese healthy participants. The entire trial cycle includes a 4-week screening period, 8-week treatment period and 8-week 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 males/females aged 18-55 years (inclusive).
- •BMI 18.0-28.0 kg/m²; weight ≥50 kg (male) or ≥45 kg (female).
- •Willing to use effective contraception for 6 months post-dosing.
排除标准
- •History of blood or needle sickness, or those who cannot tolerate venipuncture.
- •Female participants who are pregnant or breastfeeding at screening or randomization.
- •History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening.
- •History of live or attenuated vaccination within 1 month prior to screening, or those who plan to be vaccinated during the study.
研究组 & 干预措施
Placebo SC
Participants in placebo group will receive placebo SC.
干预措施: Placebo (Drug)
IBI3033 Dose 2 SC
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
干预措施: IBI3033 (Drug)
IBI3033 Dose 1 subcutaneously (SC)
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
干预措施: IBI3033 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)/serious adverse events (SAEs)
时间窗: Baseline to Day 113
Percentage of participants who have experienced AEs/SAEs
次要结局
- PK parameter: Cmax(Baseline to Day 113)
- PK parameter: tmax(Baseline to Day 113)
- PK parameter: AUC(Baseline to Day 113)
- Immunogenticity profiles(Baseline to Day 113)