A Phase 1, Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 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
Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy as determined by a responsible study physician based on medical evaluation
- •Body weight 40 to 100 kg
- •Body mass index 19.0 to 30.0 kg/m2
排除标准
- •History of allergy or sensitivity to Shellfish or protein based antigens
- •previous immunization with KLH
- •previous splenectomy
- •History of diagnosed or suspected thromboembolic event or coagulation disorder
研究组 & 干预措施
Placebo
Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
干预措施: Placebo (Other)
MEDI4920 3 mg
Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
干预措施: MEDI4920 3 mg (Biological)
MEDI4920 10 mg
Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
干预措施: MEDI4920 10 mg (Biological)
MEDI4920 30 mg
Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
干预措施: MEDI4920 30 mg (Biological)
MEDI4920 100 mg
Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
干预措施: MEDI4920 100 mg (Biological)
MEDI4920 300 mg
Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
干预措施: MEDI4920 300 mg (Biological)
MEDI4920 1000 mg
Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
干预措施: MEDI4920 1000 mg (Biological)
MEDI4920 3000 mg
Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
干预措施: MEDI4920 3000 mg (Biological)
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: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit
An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.
次要结局
- Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)
- Maximum Observed Plasma Concentration (Cmax) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)
- Percentage of Participants Positive for Anti-drug Antibodies (ADA)(Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first)
- T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration(Day 43)
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)
- Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)
- Terminal Elimination Half Life (t1/2) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)
- Systemic Clearance (CL) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)
- Volume of Distribution at Steady-state (Vss) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)
- Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920(Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first)