A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Injections of Budoprutug (TNT119) in Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants
研究概览
简要总结
The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.
详细描述
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of budoprutug administered subcutaneously (SC) in adult normal healthy volunteers (NHVs). To assess the bioavailability of the SC formulation, one cohort will receive a single intravenous (IV) dose of budoprutug. Approximately 38 participants will be enrolled across four dose cohorts, including three SC dose levels and one IV comparator group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Healthy adult males and females aged 18-60 years
- •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 6 months post-dose
- •Completion of a 2-dose primary COVID-19 vaccination series and at least 1 booster dose, as well as influenza vaccination (within 12 months)
排除标准
- •Prior treatment with investigational drugs within 30 days or 5 half-lives
- •History of hypogammaglobulinemia or significant allergic reactions
- •Recent infections, including serious local/systemic infections or opportunistic infections
- •Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis
- •Use of tobacco (>2 cigarettes/day), alcohol abuse, or recreational drugs
- •Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)
研究组 & 干预措施
Placebo
Placebo solution to be administered at a matching volume
干预措施: Placebo (Drug)
Budoprutug
Subcutaneous (SC) injection or IV administration of budoprutug
干预措施: Budoprutug (Drug)
结局指标
主要结局
Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants
时间窗: Day 57
Incidence of treatment-emergent adverse events
Incidence of infusion-related reactions (IRRs) for IV administration
时间窗: Day 57
Number of infusion-related reactions
Incidence of injection site reactions (ISRs) for SC administration
时间窗: Day 57
Number of injection site reactions
次要结局
- Time to Maximum Observed Concentration (Tmax)(Day 57)
- Area Under the Curve (AUC)(Day 57)
- Terminal Half-Life (T1/2)(Day 57)
- Bioavailability (F)(Day 57)
- Maximum Observed Plasma Concentration (Cmax)(Day 57)