A Phase 1, Randomized, Triple-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Monoclonal Antibody VYD222 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of TEAEs (including AEs and SAEs)
研究概览
简要总结
A study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody VYD222 in healthy adult participants.
详细描述
This is a Phase I, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of VYD222, a monoclonal antibody targeting SARS-CoV-2, in healthy adult volunteers.
The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD222 after a single administration in healthy participants. The secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of VYD222 after administration in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a body mass index 18.5 to 32.0 kg/m2, inclusive.
- •Negative for current SARS-CoV-2 infection by rapid antigen test on Day -
- •Is seropositive to N and/or S SARS-CoV-2 antigens at Screening.
- •For participants assigned female sex at birth: Is not of childbearing potential OR is of childbearing potential and practicing highly effective contraception.
- •Is able and willing to provide written informed consent.
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
排除标准
- •Intends to receive a COVID-19 vaccine/booster within 3 months of Day
- •Is pregnant, breastfeeding, or seeking pregnancy while on study.
- •Has a history of a malignancy (or active malignancy), except for participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix who have been treated and cured.
- •Has had any symptoms of acute respiratory illness (e.g., cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing.
- •Has evidence of active infection with HIV, HBV, or HCV.
- •Has donated more than 500 mL of blood within 60 days before the scheduled dose of study drug.
- •Had major surgery within 30 days prior to study drug dosing or planned surgeries within 12 months after planned study drug dosing.
- •Received any investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to Screening or planned administration of any investigational drug or biologic during the study period.
- •Received immunoglobulin or blood products within 6 months prior to Screening.
- •Previously received a mAb within 6 months or 5 half-lives (whichever is longer) prior to Screening.
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Cohort 1
10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
干预措施: VYD222 (Drug)
Cohort 1
10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
干预措施: Placebo (Other)
Cohort 2
10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
干预措施: VYD222 (Drug)
Cohort 2
10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
干预措施: Placebo (Other)
Cohort 3
10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
干预措施: VYD222 (Drug)
Cohort 3
10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of TEAEs (including AEs and SAEs)
时间窗: Through 12 Months
次要结局
- Incidence of ADAs against VYD222(12 Months)
- Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222(12 Months)
- Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222(12 Months)
- Assessment of PK Parameter: Cmax (maximum serum concentration)(12 Months)
- Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)(12 Months)
- Assessment of PK Parameter: volume of distribution during terminal phase of VYD222(12 Months)
- Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222(12 Months)
- Assessment of PK Parameter: Clearance of VYD222(12 Months)
- Assessment of PK Parameter: Half-life of VYD222(12 Months)
- Assessment of PK Parameter: volume of distribution at steady state of VYD222(12 Months)