A Phase I Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmacokinetic Trial of BNT331 Administered in Single Ascending Doses in Healthy Women and Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- BioNTech SE
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-dose
研究概览
简要总结
This is a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed with bacterial vaginosis (BV) (Part B).
详细描述
Part A will include single ascending dose levels and will assess the safety of BNT331 and describe the incidence of adverse events (AEs) for participants randomized at a ratio of 3:1 to BNT331 or placebo. Participants will receive one single dose of study treatment.
Part B will include multiple ascending dose levels. Participants will be randomized at a ratio of 2:1 to BNT331 or placebo. Participants with BV will receive study treatment for five consecutive days.
The vaginal inserts will be self-administered by the participant. The participants will receive detailed instructions from the investigator on how to self-administer the vaginal inserts at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Observer-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BNT331 - Part B Dose 1
Fixed dose for 5 consecutive days
干预措施: BNT331 (Drug)
BNT331 - Part A
Single ascending dose levels
干预措施: BNT331 (Drug)
Placebo - Part A
Single dose
干预措施: Placebo (Other)
BNT331 - Part B Dose 2
Fixed dose for 5 consecutive days
干预措施: BNT331 (Drug)
Placebo - Part B
Multiple dose
干预措施: Placebo (Other)
结局指标
主要结局
Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-dose
时间窗: from first dose of study treatment up to 7 days post-dose
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
Part B - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 120 days after the first dose
时间窗: from first dose of study treatment up to 120 days after first dose
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
Part A - Percentage of participants with serious adverse events (SAEs) with onset after first treatment dose and until 7 days post-dose
时间窗: from first dose of study treatment up to 7 days post-dose
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
Part B - Percentage of participants with SAEs with onset after first treatment dose and until 120 days after the first dose
时间窗: from first dose of study treatment up to 120 days after first dose
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
次要结局
- Part A - Serum concentrations of BNT331 active substance at pre-specified timepoints(from pre-dose up to 12 days post-dose)
- Part B - Serum concentrations of BNT331 active substance at pre-specified timepoints(from pre-dose up to 30 days after first dose)
- Part A - Anti-drug antibody (ADA) prevalence and change of binding titers against BNT331 active substance in blood before study treatment and at 7 days post-dose(from pre-dose up to 7 days post-dose)
- Part B - ADA prevalence and change of binding titers against BNT331 active substance in blood before study treatment and at 6 days after the first dose, 21 to 30 days after the first dose, and 120 days after the first dose(from pre-dose up to 120 days after first dose)
- Part B - Number of participants with clinical cure(At 6 days after first dose and 21 to 30 days after the first dose)
- Part B - Number of participants with Nugent score cure/Microbiological cure(At 6 days after first dose and 21 to 30 days after the first dose)
- Part B - Responder outcome - Number of participants with clinical cure and normal Nugent score of <4(At 6 days after first dose and 21 to 30 days after the first dose)