Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
60
Countries
1
Sites
1
NA - healthy volunteers
Key facts
- Sponsor
- Quralis Corp.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 24 Jun 2024 → 14 Jan 2025
- Decision date (initial)
- 2024-06-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
NA - healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Quralis Corp.
- Sponsor organisation
- Quralis Corp.
- Address
- 100 Cambridge Park Drive
- City
- Cambridge
- Postcode
- 02140-2369
- Country
- United States
Scientific contact point
- Organisation
- Quralis Corp.
- Contact name
- Thomas Bowman, MD
Public contact point
- Organisation
- Quralis Corp.
- Contact name
- Principal Investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 60 | 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 | 2024-06-24 | 2025-01-14 | 2024-06-24 | 2025-01-14 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | Netherlands | Acceptable 2024-06-20
|
2024-06-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-21 | Netherlands | Acceptable 2024-06-20
|
2024-10-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-01-13 | Netherlands | Acceptable 2024-06-20
|
2025-01-13 |