Clinical trial • Phase I • Infectious Disease
INE963 for Malaria
Phase I trial of INE963 for Malaria. 114 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Malaria
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 28-02-2025
- First CTIS Authorization Date
- 09-04-2025
Trial design
Phase I trial across 1 site in Netherlands.
- Target Sample Size
- 114
Eligibility
Recruits 114 Healthy volunteers; isVulnerablePopulationSelected is false; no consent or assent details provided..
- Vulnerable Population
- Healthy volunteers; isVulnerablePopulationSelected is false; no consent or assent details provided.
Recruitment
- Planned Sample Size
- 114
- Recruitment Window Months
- 11
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 114
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-04-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 333
- Number Of Sites
- 1
- Number Of Participants
- 114
Sites
- Site Name
- Pharma Bio-Research Group
- Department Name
- Program Management
- Contact Person Name
- Renger Tiessen
- Contact Person Email
- Renger.Tiessen@iconplc.com
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- INE963
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