A Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231, Encoding for a Human Serum Albumin - Interleukin-2 Mutein Fusion Protein (HSA-IL2m), in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs) and Serious AEs
研究概览
简要总结
There are 2 parts to this study: a single ascending dose (single dose of mRNA-6231) part and a multiple ascending dose (repeat doses of mRNA-6231) part. The main goal of this study is to evaluate the safety and tolerability of escalating doses of single and repeat subcutaneous (SC) administration of mRNA-6231. Dose levels of mRNA-6231 are planned to be investigated in a dose-escalation manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Understand and agree to comply with the study procedures and provide written informed consent
排除标准
- •Has received any investigational product (for example, study drug, biologic, device) within 30 days or 5 elimination half-lives, whichever is longer
- •Pregnant or lactating women
- •Men and women of childbearing potential without effective contraception during the study
- •Has any lab abnormalities or clinically significant medical condition that could interfere with the interpretation of study results or limit the participant's enrollment
研究组 & 干预措施
mRNA-6231 Dose Level 1
In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 1 of mRNA-6231 by subcutaneous injection on Day 1.
In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 1 of mRNA-6231 once every 2 weeks.
干预措施: mRNA-6231 (Drug)
mRNA-6231 Dose Level 2
In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 2 of mRNA-6231 by subcutaneous injection on Day 1.
In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 2 of mRNA-6231 once every 2 weeks.
干预措施: mRNA-6231 (Drug)
mRNA-6231 Dose Level 3
In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 3 of mRNA-6231 by subcutaneous injection on Day 1.
In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 3 of mRNA-6231 once every 2 weeks.
干预措施: mRNA-6231 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) and Serious AEs
时间窗: Up to Day 84
次要结局
- Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma)(Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29)
- Time to Maximum to Observed Effect (TEmax) of mRNA-6231(Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29)
- Maximum Observed Effect (Emax) of mRNA-6231(Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29)
- Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231(Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29)
- Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)(Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29)