A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis
NCT Number: NCT06469164
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Bacterial Vaginosis
Interventions: DRUG: BNT331|OTHER: Placebo
Sponsor: BioNTech SE
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2025-05
Locations: UAB Sexual Health Research Clinic, Birmingham, Alabama, 35294-0007, United States|Praetorian Pharmaceutical Research, LLC, Marrero, Louisiana, 70072, United States|Southern Clinical Research Associates - Metairie, Metairie, Louisiana, 70001, United States|Women Under Study, LLC, New Orleans, Louisiana, 70125, United States|Nucleus Network, Saint Paul, Minnesota, 55114, United States|Velocity clinical Resesarch, Norfolk, Norfolk, Nebraska, 68701, United States

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).

Primary Outcome Measures: Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until the Follow-up Visit, 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., from first dose of study treatment up to 12 days post-dose|Part B - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until Late Follow-up Visit, 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., from first dose of study treatment up to 127 days post-first dose|Part A - Percentage of participants with serious adverse events (SAEs) with onset after first treatment dose and until the Follow-up Visit, 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., from first dose of study treatment up to 12 days post-dose|Part B - Percentage of participants with SAEs with onset after first treatment dose and until the Late Follow-up Visit, 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., from first dose of study treatment up to 127 days post-first dose
Secondary Outcome Measures: Part A - Serum concentrations of BNT331 active substance at pre-specified timepoints, For each dose level cohort of BNT331. In participants who received one single administration., from pre-dose up to 12 days post-dose|Part B - Serum concentrations of BNT331 active substance at pre-specified timepoints, For each dose level cohort of BNT331. In participants who received all scheduled administrations., from pre-dose up to 30 days post-first dose|Part A - Anti-drug antibody (ADA) prevalence or change of binding titers against BNT331 active substance in blood before study treatment and at the Follow-up Visit, For each dose level cohort of BNT331, from pre-dose up to 12 days post-dose|Part B - ADA prevalence or change of binding titers against BNT331 active substance in blood before study treatment and at the Test of Cure (ToC) Visit, For each dose level cohort of BNT331, from pre-dose up to 30 days post-first dose|Part B - Number of participants with clinical cure, For each dose level cohort of BNT331 and for the combined placebo group. Normalization of the vaginal discharge, a negative potassium hydroxide (KOH) "Whiff" test, and clue cells \<20% of the total epithelial cells/high power field on microscopic examination of the vaginal fluid., from 6 days post-first dose up to 30 days post-first dose|Part B - Number of participants with Nugent score cure/Microbiological cure, For each dose level cohort of BNT331 and for the combined placebo group. Nugent score of \<4., from 6 days post-first dose up to 30 days post-first dose|Part B - Responder outcome - Number of participants with clinical cure and normal Nugent score of <4, For each dose level cohort of BNT331 and for the combined placebo group., from 6 days post-first dose up to 30 days post-first dose