A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
The purpose of this study was to evaluate the safety, tolerability and pharmacokinetics of an extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to placebo when administered to healthy adult participants.
详细描述
This was a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI8897 compared to placebo when administered to healthy adult participants. There were 136 participants randomized to receive MEDI8897 or placebo at one site. Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts. 4 different dose levels of investigational product were evaluated across the 5 cohorts. Participants were followed for approximately 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 through 49 years and in good health by history, physical exam, and labs
- •Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=) 110 kg at Screening
- •Written informed consent prior to performing any protocol related procedures, including Screening evaluations
- •Ability to complete the Follow-up period of 360 days
排除标准
- •Acute illness including fever >= 99.5 Fahrenheit (°F) on day of dosing
- •Any drug therapy within 7 days prior to Day 1 (except contraceptives)
- •Receipt of any investigational drug therapy within 120 days prior to investigational product dosing through 360 days after investigational product dosing
- •Previous receipt of a monoclonal antibody (mAb)
- •Pregnant or nursing mother
- •Concurrent enrollment in another interventional study
研究组 & 干预措施
MEDI8897 300 milligram (mg) Intravenous (IV)
Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
干预措施: MEDI8897 Intravenous (Drug)
MEDI8897 1000 mg IV
Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
干预措施: MEDI8897 Intravenous (Drug)
MEDI8897 3000 mg IV
Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
干预措施: MEDI8897 Intravenous (Drug)
MEDI8897 100 mg Intramuscular (IM)
Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
干预措施: MEDI8897 Intramuscular (Drug)
MEDI8897 300 mg IM
Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
干预措施: MEDI8897 Intramuscular (Drug)
Placebo
Participants received placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
时间窗: From start of study drug administration up to Day 391 (Day 361 +/- 30 days)
An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.
次要结局
- Maximum Observed Serum Concentration (Cmax) for MEDI8897(Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361)
- Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897(Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361)
- Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897(Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361)
- Terminal Phase Elimination Half Life (t1/2) for MEDI8897(Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361)
- Systemic Clearance (CL) for MEDI8897(Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361)
- Volume of Distribution (Vz) for MEDI8897(Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361)
- Number of Participants With Positive Anti-Drug Antibody (ADA)(Predose and Day 15, 31, 91, 181, 271 and 361)