NCT06655870招募中1 期
A Phase 1, Single-Center, Open-label, Single Ascending Dose and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of mRNA-0184 Administered Subcutaneously in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) Including Injection Site Reactions (ISRs), Adverse Events of Special Interests (AESIs), and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to test the safety of mRNA-0184 in healthy participants.
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
- None
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
- •Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and vital signs.
- •Body weight within 50 to 100 kilograms (kg) (inclusive) and body mass index within 18 to 32 kg/square meter (m^2) (inclusive) at Screening.
- •Participant who could become pregnant must meet conditions as defined in the protocol.
排除标准
- •History of any clinically significant disease or disorder, including bleeding disorders and wound healing disorders, which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
- •Any clinically significant illness, or medical/surgical procedure, within 4 weeks of the first administration of the study drug (mRNA-0184).
- •Any clinically significant abnormalities in clinical laboratory results at Screening. Repeat assessments are allowed at the Investigator's discretion if a false positive is suspected.
- •Clinically significant abnormal findings in vital signs at Screening.
- •Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
- •Use of any prescribed medication or over-the-counter (OTC) medication that may have an impact on the interpretation of study analyses in the opinion of the Investigator during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of the study drug. Such prescribed or OTC medications are also not permitted during participation in the study. Hormonal contraception is permitted.
- •Participation in another clinical study of another drug product (DP) within 30 days before Screening or within 5 terminal half-lives of the DP, whichever is longer.
研究组 & 干预措施
Single Ascending Dose (SAD): mRNA-0184
Experimental
Participants will receive a single subcutaneous (SC) injection of a fixed dose of mRNA-0184 on Day 1.
干预措施: mRNA-0184 (Drug)
Repeat-Dose: mRNA-0184
Experimental
Participants will receive up to 2 SC injections of a fixed dose of mRNA-0184 on Days 1 and 15.
干预措施: mRNA-0184 (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs) Including Injection Site Reactions (ISRs), Adverse Events of Special Interests (AESIs), and Serious Adverse Events (SAEs)
时间窗: Day 1 through Day 50
次要结局
- Serum Concentrations of Study Drug(Day 1 through Day 50)
- Serum Concentrations of Relaxin-2-variable Light Chain Kappa (Rel2- vlk) Protein(Day 1 through Day 50)
- Maximum Observed Response (Emax) of Rel2- vlk Protein(Day 1 through Day 50)
- Area Under the Effect-time Curve (AUEC) of of Rel2- vlk Protein(Day 1 through Day 50)
- Number of Participants with Anti-Polyethylene Glycol (PEG) Antibodies(Day 1 through Day 50)
- Number of Participants with Anti-Rel2-vlk Protein Antibodies(Day 1 through Day 50)
- Maximum Observed Plasma Concentration (Cmax) of Study Drug(Day 1 through Day 50)
- Area Under the Concentration-time Curve from Time 0 to Last Quantifiable Concentration (AUC0-t) of Study Drug(Day 1 through Day 50)
- Area Under the Effect-time Curve (AUEC) of Rel2- vlk Protein(Day 1 through Day 50)
研究者
研究点 (2)
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