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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 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
研究组 & 干预措施
Placebo
Placebo Comparator
Saline
干预措施: Placebo (Other)
mRNA-1944
Experimental
Escalating dose levels
干预措施: mRNA-1944 (Biological)
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 (1)
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