A Phase 2, Open-Label, Long-Term Study to Evaluate the Safety, Pharmacokinetics, and Occurrence of Anti-Drug Antibodies in Healthy Participants Following Annual Doses of CD388, a Novel Long-Acting Antiviral Conjugate
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- Number of Participants with Treatment-Induced Anti-Drug Antibodies (ADAs)
研究概览
简要总结
The goal of this clinical study is to learn if giving repeated annual doses of MK-1406 (CD388) is safe and how the body reacts to it in healthy adults who have already received one dose without serious side effects. The study aims to determine if the body makes antibodies against MK-1406 after repeated doses, which might affect how the drug works or how safe it is, and to better understand the safety and tolerability of repeated doses. Participants will receive two doses of MK-1406 over two years and be monitored for 18 months. Researchers will check for immune responses against the drug, watch for any side effects, and measure how the drug behaves in the body over time. This study is based on the idea that people who tolerated MK-1406 well before will likely continue to tolerate it safely with repeated annual dosing, and that the risk of immune reactions will remain low.
详细描述
This is a Phase 2, open-label, long-term study to evaluate the occurrence anti-drug antibodies (ADAs) directed to MK-1406 (CD388) following administration of 2 annual doses of MK-1406 in healthy participants during an 18-month period. All participants previously completed study CD388.SQ.2.05/MK-1406-004, having received a dose of the active drug without experiencing any serious adverse events (SAEs) during that study. This study will also evaluate the safety and tolerability of MK-1406 and the pharmacokinetics (PK) of MK-1406 following repeated annual dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Be in stable health
- •Has previously completed participation in study CD388.SQ.2.05/MK-1406-004, and received a subcutaneous (SC) CD388/MK-1406 dose of either 150 mg, 300 mg or 450 mg.
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Have a contraindication to subcutaneous (SQ) injections and venipunctures (eg, bleeding disorders).
- •Has a known or suspected allergy or history of anaphylaxis or other serious adverse events (SAEs) to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibodies, or any of the components of CD388/MK-1406.
研究组 & 干预措施
MK-1406
Participant will receive 450 mg dose of MK-1406 (CD388) by subcutaneous (SC) injection followed 1 year later by a repeat single 450 mg dose of MK-1406 administered by SC injection.
干预措施: MK-1406 Injection (Combination Product)
结局指标
主要结局
Number of Participants with Treatment-Induced Anti-Drug Antibodies (ADAs)
时间窗: Periods 1 and 2: Day 1, Day 29, Day 85, Day 169, and Day 197
Participants are evaluated for the occurrence of treatment-induced ADAs following administration of each annual dose of MK-1406.
Number of Participants with Treatment-Boosted ADAs
时间窗: Periods 1 and 2: Day 1, Day 29, Day 85, Day 169, and Day 197
Participants are evaluated for the occurrence of treatment-boosted ADAs following administration of each annual dose of MK-1406.
Occurrence of Anti-Drug Antibodies (ADAs) in Participants Administered CD388
时间窗: On Day 1 (pre-dose baseline), Day 29, Day 85, Day 169, and Day 197 in Study Period 1; on Day 1 (pre-dose), Day 29, Day 85, Day 169, and Day 197/End of Study (EOS) in Study Period 2
Evaluation of blood serum samples for the occurrence of treatment-emergent anti-drug antibodies (ADAs) or treatment-boosted ADAs (based on an increase in ADA titer in samples positive for ADA at baseline) directed to CD388 in participants following administration of each annual dose of CD388.
次要结局
- Number of participants with ≥1 Adverse Event (AE)(Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197.)
- Number of Participants Who Discontinued from the Study Due to an AE(Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197.)
- Number of Participants with a Solicited Injection-site AE(Up to approximately Day 8 post dose)
- Number of Participants with a Serious Adverse Event (SAE)(Period 1: Up to approximately Day 280. Period 2: Up to approximately Day 197.)
- Plasma Concentration Following Administration of MK-1406(Periods 1 and 2: Pre-dose, Day 8, Day 29, Day 85, Day 169, Day 197)
- Plasma concentration of MK-1406 by anti-drug antibody (ADA) status.(Periods 1 and 2: Day 197)
- Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug(From Study Period 1 Day 1 after study drug dosing through Study Period 2 Day 197/EOS)
- Plasma Concentrations at Specified Timepoints Following Administration of CD388(In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 8, Day 29, Day 85, Day 169, and Day 197/EOS as applicable)
- Trough Plasma Concentration at 24 Weeks (C[trough24w]) Following Administration of CD388(In both Study Periods 1 and 2 on Day 169)
- Maximum Plasma Concentration (C[max]) Following Administration of CD388(In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 8, Day 29, Day 85, Day 169, and Day 197/EOS as applicable)
- Area Under the Plasma Concentration-Time Curve (AUC) Following Administration of CD388(In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 8, Day 29, Day 85, Day 169, and Day 197/EOS as applicable)
- Correlation of Plasma Concentration of CD388 and Titer of Anti-CD388 Antibodies at Time Points Where ADAs are Present(In both Study Periods 1 and 2 on Day 1 (pre-dose), Day 29, Day 85, Day 169, and Day 197/EOS as applicable)