A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose (SAD) and Multiple-Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection(s) of CLYM116 in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of injection site reactions Number of injection site reactions
研究概览
简要总结
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
详细描述
CLYM116 is a humanized monoclonal antibody that selectively binds to a proliferation inducing ligand (APRIL). This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of CLYM116 in adult normal healthy volunteers (NHVs). The study will enroll up to 48 subjects, across up to five cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and females aged 18-60 years, inclusive
- •Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg
- •Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant)
- •Willing and able to comply with study procedures and provide informed consent
- •Women of childbearing potential must use highly effective contraception and have negative pregnancy tests
- •Men must use contraception and refrain from sperm donation for 4 months post-dose
- •Completion of COVID-19 vaccination according to local guidelines, as well as influenza vaccination (within 12 months)
排除标准
- •Prior treatment with investigational drugs within 30 days or 5 half-lives
- •Previous or current hypogammaglobulinemia
- •Current presence of allergic reactions considered clinically significant
- •Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis
- •Tobacco use (>2 cigarettes/day), alcohol abuse, or drug abuse
- •Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)
研究组 & 干预措施
CLYM116
Subcutaneous (SC) injection of CLYM116
干预措施: CLYM116 (Drug)
Placebo
Subcutaneous (SC) injection of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of injection site reactions Number of injection site reactions
时间窗: From Baseline through to Day 4 and Day 15 to Day 18
Safety and tolerability of single and multiple ascending doses of CLYM116 in healthy volunteers Incidence of treatment-emergent adverse events
时间窗: From Screening through to Day 85, or final follow-up visit
次要结局
- Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time(From Screening through to Day 85, or final follow-up visit)
- Level of APRIL Measurement of APRIL in pg/mL and changes over time(Day -1, Baseline, Day 1, Day 4, Day 8, Day 14, Day 15, Day 17, Day 18, Day 22, Day 29, Day 71, day 85, final follow up visit)
- Immunogenicity Measurement of CLYM116 antidrug antibodies (ADA)(Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit)
- Maximum Observed Plasma Concentration (Cmax) Measurement of the maximum observed plasma concentration.(From Baseline through to Day 85 (except Day 14), or final follow-up visit)
- Time to Maximum Observed Concentration (Tmax) Measurement of the time to maximum observed concentration.(From Baseline through to Day 85 (except Day 14), or final follow-up visit)
- Area Under the Curve (AUC) Measurement of the area under the drug concentration-time curve.(From Baseline through to Day 85 (except Day 14), or final follow-up visit.)
- Half-Life (T1/2) Measurement of the half-life in days(From Baseline through to Day 85 (except Day 14), or final follow-up visit)