Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
1
Alzheimer’s Disease
Key facts
- Sponsor
- Taurx Therapeutics Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 18 Mar 2024 → 17 May 2024
- Decision date (initial)
- 2024-01-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10001897 | Alzheimer's disease (incl subtypes) | 10037175 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Taurx Therapeutics Limited
- Sponsor organisation
- Taurx Therapeutics Limited
- Address
- Sir Moir Lockhead Building 1st Floor, 395 King Street 395 King Street
- City
- Aberdeen
- Postcode
- AB24 5RP
- Country
- United Kingdom
Scientific contact point
- Organisation
- Taurx Therapeutics Limited
- Contact name
- Sotereos Gates
Public contact point
- Organisation
- Taurx Therapeutics Limited
- Contact name
- Sotereos Gates
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2024-03-18 | 2024-05-17 | 2024-03-18 | 2024-04-08 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-18 | Netherlands | Acceptable 2024-01-31
|
2024-01-31 |