Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
16
Countries
1
Sites
1
AMYOTROPHIC LATERAL SCLEROSIS
Key facts
- Sponsor
- Tranquis Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2023-10-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504746-54-00
- WHO UTN
- U1111-1290-3098
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
AMYOTROPHIC LATERAL SCLEROSIS
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tranquis Therapeutics Inc.
- Sponsor organisation
- Tranquis Therapeutics Inc.
- Address
- 3 Lagoon Drive Suite 130
- City
- Redwood City
- Postcode
- 94065-1566
- Country
- United States
Scientific contact point
- Organisation
- Tranquis Therapeutics Inc.
- Contact name
- Rauno Oja
Public contact point
- Organisation
- Tranquis Therapeutics Inc.
- Contact name
- Rauno Oja
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Latvia | Authorised, recruitment pending | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-27 | Latvia | Acceptable 2023-10-09
|
2023-10-11 |