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
Overview
- Phase
- Phase 1
- Intervention
- BNT331
- Conditions
- Bacterial Vaginosis
- Sponsor
- BioNTech SE
- Enrollment
- 102
- Locations
- 6
- Primary Endpoint
- Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-dose
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BNT331 - Part B Dose 1
Fixed dose for 5 consecutive days
Intervention: BNT331
BNT331 - Part A
Single ascending dose levels
Intervention: BNT331
Placebo - Part A
Single dose
Intervention: Placebo
BNT331 - Part B Dose 2
Fixed dose for 5 consecutive days
Intervention: BNT331
Placebo - Part B
Multiple dose
Intervention: Placebo
Outcomes
Primary Outcomes
Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-dose
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)