A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple-dose Escalation Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of XmAb412 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Xencor, Inc.
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb412 in healthy adult participants (Part A and Part B)
研究概览
简要总结
This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants
详细描述
This study consists of 2 parts, as follows:
In Part A, participants will receive a single dose of XmAb412 using subcutaneous (SC) or intravenous (IV) administration route.
In Part B, participants will receive multiple doses of XmAb412 or placebo using SC or IV administration route.
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
- Double (Participant, Investigator)
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
- •Age 18-55 years old
- •Must be in good health with no significant medical history
- •BMI 18-35 kg/m2
- •Contraceptive use consistent with local regulations
- •Able and willing to provide written informed consent
排除标准
- •Any physical condition that prohibits study completion
- •Known hypersensitivity to the trial intervention or any of its components
- •HIV, hepatitis B and hepatitis C positive
- •Clinically significant abnormal ECG
- •Use of other investigational products within 5 half lives from Screening
- •Blood or plasma donation within 60 days from Screening
- •Pregnant or breastfeeding
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A: Active Drug
Active XmAb412 to be administered to healthy adult participants.
干预措施: XmAb412 Monoclonal Bispecific Antibody (Drug)
Part A: Placebo
Placebo Comparator to be administered to healthy participants.
干预措施: Placebo (Drug)
Part B: Active
Active XmAb412 to be administered to healthy participants.
干预措施: XmAb412 Monoclonal Bispecific Antibody (Drug)
Part B: Placebo
Placebo Comparator to be administered to healthy participants.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb412 in healthy adult participants (Part A and Part B)
时间窗: Up to 28 weeks
次要结局
- Tmax (Time of maximum concentration of drug)(Up to 28 weeks)
- • t1/2 (terminal elimination half-life(Up to 28 weeks)
- • CL/F (apparent) total body clearance(Up to 28 weeks)
- • Vz/F (apparent volume of distribution(Up to 28 weeks)
- • AUC0-last (Area under the curve drug concentration-time curve to last concentration)(Up to 28 weeks)
- • Repeat dose cohorts: AUC0-tau (AUC within a dosing interval(Up to 28 weeks)
- Serum PK parameters of XmAb412 in healthy adult participants (Part A and Part B)(Up to 28 weeks)
- Cmax (Maximum concentration of drug)(Up to 28 weeks)
- • AUC0-inf (AUC from time 0 extrapolated to infinity(Up to 28 weeks)