NCT04736134已完成1 期
A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Administration of BMS-986326 in Healthy Participants
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年3月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this study will guide the selection of the dose range, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health, as determined by the investigator based on a physical examination at screening
- •Body mass index (BMI) ≥ 18 and ≤ 30 kg/m^2 at screening
- •Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening
- •Male participants are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)
- •Must agree to follow specific methods of contraception, if applicable
排除标准
- •Women who are pregnant or lactating
- •History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
- •History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 175 days
Number of participants with physical examinations abnormalities
时间窗: Up to 175 days
Number of participants with clinical laboratory abnormalities
时间窗: Up to 175 days
Number of participants with vital sign abnormalities
时间窗: Up to 175 days
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to 175 days
次要结局
- Maximum observed serum concentration (Cmax)(Up to 175 days)
- Time of maximum observed serum concentration (Tmax)(Up to 175 days)
- Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio(Up to 175 days)
- Number of participants with anti-drug antibodies(Up to 175 days)
- Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)](Up to 175 days)
- Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)](Up to 175 days)
- Change in regulatory T cells (Treg) count(Up to 175 days)
研究者
研究点 (2)
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