Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
1
Stroke
Key facts
- Sponsor
- Algernon Pharmaceuticals Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 15 Nov 2022 → ongoing
- Decision date (initial)
- 2024-11-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518020-68-00
- EudraCT number
- 2022-002411-30
- ClinicalTrials.gov
- NCT05559931
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Stroke
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Algernon Pharmaceuticals Inc.
- Sponsor organisation
- Algernon Pharmaceuticals Inc.
- Address
- 601 Broadway West Suite 400
- City
- Vancouver
- Postcode
- V5Z 4C2
- Country
- Canada
Scientific contact point
- Organisation
- Algernon Pharmaceuticals Inc.
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Algernon Pharmaceuticals Inc.
- Contact name
- Principal Investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
n.a., Zernikedreef 8, 2333 CL, Leiden
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2022-11-15 | 2022-11-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Netherlands | Acceptable 2024-11-21
|
2024-11-21 |