Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
200
Countries
1
Sites
2
Parkinson’s disease
Key facts
- Sponsor
- Vanqua Bio Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 25 Jan 2024 → ongoing
- Decision date (initial)
- 2024-01-25
- 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
Parkinson’s disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vanqua Bio Inc.
- Sponsor organisation
- Vanqua Bio Inc.
- Address
- 1375 West Fulton Street Suite 600
- City
- Chicago
- Postcode
- 60607-1157
- Country
- United States
Scientific contact point
- Organisation
- Vanqua Bio Inc.
- Contact name
- Brieana Sommer
Public contact point
- Organisation
- Vanqua Bio Inc.
- Contact name
- Brieana Sommer
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 200 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-01-25 | 2024-01-31 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-27 | Netherlands | Acceptable 2024-01-25
|
2024-01-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-21 | Netherlands | Acceptable 2024-01-25
|
2024-03-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-22 | Netherlands | Acceptable 2024-04-03
|
2024-04-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-17 | Netherlands | Acceptable 2024-05-01
|
2024-05-01 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-03 | Netherlands | Acceptable 2024-05-01
|
2024-05-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-06 | Netherlands | Acceptable 2024-10-04
|
2024-10-04 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-08 | Netherlands | Acceptable 2024-10-24
|
2024-10-24 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-06 | Netherlands | Acceptable 2024-12-16
|
2024-12-16 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-23 | Netherlands | Acceptable 2025-02-04
|
2025-02-04 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-18 | Netherlands | Acceptable 2025-03-27
|
2025-03-28 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-24 | Netherlands | Acceptable 2025-03-27
|
2025-04-24 |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-27 | Netherlands | Acceptable 2025-07-14
|
2025-07-14 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-08-22 | Netherlands | Acceptable 2025-09-24
|
2025-09-24 |