NCT03829384已完成1 期
A Phase 1, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944, Encoding for an Anti-Chikungunya Virus Monoclonal Antibody, in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
研究概览
简要总结
This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects. Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Male or female ≥ 18 and ≤ 50 years of age
- •Weight of 50 to 100 kg, inclusive
- •In good general health as determined by medical history, clinical laboratory assessments, ECG results, vital sign measurements, and physical examination findings at screening
- •Has access to consistent and reliable means of contact and agrees to stay in contact with the study site for the duration of the study
排除标准
- •Any acute or chronic clinically significant disease, as determined by physical examination or laboratory screening tests
- •Elevated liver function tests or safety laboratory test results
- •Positive screening test for the presence of anti-CHIKV IgG
- •Administration of another investigational study involving any investigational product within 60 days or 5 half-lives, whichever is longer
- •Has received any live attenuated or inactive vaccines within 4 weeks prior to check-in, or plans to receive any vaccine during the study
- •Known or suspected immune-mediated disease or immunosuppressive condition (including lymphoproliferative disorders)
- •Any neurologic disorder
- •History of idiopathic urticaria
- •Any bleeding disorder that is considered a contraindication to study drug infusion or blood collection
- •Receipt of immunoglobulins, a monoclonal antibody or any blood products within the preceding 6 months
- •Any acute illness at the time of enrollment
- •A positive test result for drugs of abuse
- •A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies
- •A history of active cancer (malignancy) in the last 3 years
- •Donation of ≥ 450 mL blood or blood products within 30 days of study drug infusion
结局指标
主要结局
Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
时间窗: Through 13 months of study participation
次要结局
- Area under the concentration versus time curve (AUC)(Baseline through 28 days post dose)
- Maximum observed serum concentration (Cmax) after administration of mRNA-1944(Baseline through 28 days post dose)
- Time of Cmax (tmax)(Baseline through 28 days post dose)
- Terminal elimination half-life (t1/2)(Baseline through 28 days post dose)
- Maximum observed effect (Emax) for chikungunya virus IgG(Baseline through 13 months)
- Time to maximum observed effect for (TEmax) for chikungunya virus IgG(Baseline through 13 months)
- Area under the effect curve (AUEC) for chikungunya virus IgG(Baseline through 13 months)
研究者
研究点 (2)
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