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
- Registration Number
- NCT06469164
- Lead Sponsor
- BioNTech SE
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 102
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BNT331 - Part B Dose 1 BNT331 Fixed dose for 5 consecutive days BNT331 - Part B Dose 2 BNT331 Fixed dose for 5 consecutive days BNT331 - Part A BNT331 Single ascending dose levels Placebo - Part A Placebo Single dose Placebo - Part B Placebo Multiple dose
- Primary Outcome Measures
Name Time Method Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-dose 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 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 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 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 Outcome Measures
Name Time Method Part A - Serum concentrations of BNT331 active substance at pre-specified timepoints from pre-dose up to 12 days post-dose For each cohort. In participants who received one single administration.
Part B - Serum concentrations of BNT331 active substance at pre-specified timepoints from pre-dose up to 30 days after first dose For each cohort. In participants who received all scheduled administrations.
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 For each cohort.
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 For each cohort.
Part B - Number of participants with clinical cure At 6 days after first dose and 21 to 30 days after the first dose For each cohort of BNT331 group 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.
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 For each cohort of BNT331 group and for the combined placebo group. Nugent score of \<4.
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 For each cohort of BNT331 group and for the combined placebo group.
Trial Locations
- Locations (6)
UAB Sexual Health Research Clinic
🇺🇸Birmingham, Alabama, United States
Praetorian Pharmaceutical Research, LLC
🇺🇸Marrero, Louisiana, United States
Southern Clinical Research Associates - Metairie
🇺🇸Metairie, Louisiana, United States
Women Under Study, LLC
🇺🇸New Orleans, Louisiana, United States
Nucleus Network
🇺🇸Saint Paul, Minnesota, United States
Chattanooga Medical Research, LLC
🇺🇸Chattanooga, Tennessee, United States