Clinical trial • Phase I • Infectious Disease
Debio 1453P for Gonorrhoea | Sexually transmitted infection
Phase I trial of Debio 1453P for Gonorrhoea | Sexually transmitted infection. 112 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Gonorrhoea | Sexually transmitted infection
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 10-04-2025
- First CTIS Authorization Date
- 03-06-2025
Trial design
Phase I trial across 1 site in Belgium.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 112
Eligibility
Recruits 112 Vulnerable population selected (isVulnerablePopulationSelected: true). No details on consent or assent handling available in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). No details on consent or assent handling available in the record.
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 112
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 339
- Number Of Sites
- 1
- Number Of Participants
- 112
Sites
- Site Name
- SGS Belgium
- Department Name
- SGS Belgium NV – Clinical Pharmacology Unit
- Contact Person Name
- Katrin Van Leuven
- Contact Person Email
- katrin.vanleuven@sgs.com
Sponsor
Primary sponsor
- Full Name
- Debiopharm International S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- SGS Belgium
- Responsibilities
- Clinical Pharmacology Unit / trial site and contact (site contact: katrin.vanleuven@sgs.com)
Investigational products
- Investigational Product Name
- Debio 1453P
- Routes Of Administration
- oral
- Route
- oral
- First In Human
- Yes
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