Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
40
Countries
1
Sites
1
Amyotrophic lateral sclerosis (ALS)
Key facts
- Sponsor
- Projenx Inc.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 12 Jul 2024 → ongoing
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507363-20-00
- ClinicalTrials.gov
- NCT05279755
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Amyotrophic lateral sclerosis (ALS)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Projenx Inc.
- Sponsor organisation
- Projenx Inc.
- Address
- 3960 Broadway
- City
- New York
- Postcode
- 10032-1543
- Country
- United States
Scientific contact point
- Organisation
- Projenx Inc.
- Contact name
- VP Research and Development
Public contact point
- Organisation
- Projenx Inc.
- Contact name
- VP Research and Development
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 14 | 1 |
| Rest of world
United States, Canada
|
— | 26 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
Neurology & Neurosurgery, Universiteitsweg 99/100, 3584 CG, Utrecht
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 | 2024-07-12 | 2024-07-16 | 2026-03-11 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-11 | Netherlands | Acceptable 2024-01-29
|
2024-02-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-03 | Netherlands | Acceptable 2024-06-21
|
2024-06-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-29 | Netherlands | Acceptable 2024-10-14
|
2024-10-21 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-30 | Netherlands | Acceptable 2024-10-14
|
2025-01-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-28 | Netherlands | Acceptable 2025-07-07
|
2025-07-10 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-10 | Netherlands | Acceptable 2025-07-07
|
2025-10-10 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-19 | Netherlands | Acceptable 2026-02-19
|
2026-02-19 |