Clinical trial • Phase I • Neurology
THN391 for Alzheimer's disease
Phase I trial of THN391 for Alzheimer's disease. Randomised, placebo control (placebo comparator; dose/schedule not specified). 20 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Alzheimer's disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 03-01-2025
- First CTIS Authorization Date
- 14-04-2025
Trial design
Randomised, placebo control (placebo comparator; dose/schedule not specified) Phase I trial across 2 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Placebo control (placebo comparator; dose/schedule not specified)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 20
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 20
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 409
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- CTC Netherlands B.V.
- Department Name
- -
- Contact Person Name
- Khalid Abd-Elaziz
- Contact Person Email
- khalid.abdelaziz@ctc-netherlands.com
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Alzheimer Center Amsterdam, Dept. Neurology
- Contact Person Name
- E.G.B. (Jort) Vijverberg
- Contact Person Email
- ctis@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- Therini Bio Inc.
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- THN391
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