Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469164
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-17
Brief Title:
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
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 31 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 21 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
Part B will include multiple ascending dose levels Participants will be randomized at a ratio of 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None