Clinical trial • Phase I • Infectious Disease
BNT351 for HIV-1 infection
Phase I trial of BNT351 for HIV-1 infection. None/Not specified-controlled. 55 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV-1 infection
- Trial Stage
- Phase I
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-10-2025
- First CTIS Authorization Date
- 22-12-2025
Trial design
None/Not specified-controlled Phase I trial across 2 sites in Germany.
- Comparator
- None/Not specified
- Target Sample Size
- 55
Eligibility
Recruits 55 Vulnerable population selected (isVulnerablePopulationSelected: true); no details on consent or assent handling available in the source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true); no details on consent or assent handling available in the source.
Recruitment
- Planned Sample Size
- 55
- Recruitment Window Months
- 15
- Consent Approach
- Not specified in the source
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 55
Germany
- Earliest CTIS Part Ii Submission Date
- 11-12-2025
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 40
- Number Of Sites
- 2
- Number Of Participants
- 55
Sites
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Klinik für Innere Medizin
- Contact Person Name
- Clara Lehmann
- Contact Person Email
- clara.lehmann@uk-koeln.de
- Site Name
- CRS Clinical Research Services Mannheim GmbH
- Department Name
- Clinical Pharmacology Unit
- Contact Person Name
- Marina Streckenbein
- Contact Person Email
- marina.streckebein@crs-group.de
Sponsor
Primary sponsor
- Full Name
- BioNTech SE
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BNT351
- Active Substance
- BNT351
- Modality
- Monoclonal antibody
- Authorisation Status
- Investigational
Related trials
Other published trials that may interest you.