Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
72
Countries
1
Sites
1
metabolic bone diseases
Key facts
- Sponsor
- Mesentech Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 11 Aug 2023 → 18 Nov 2024
- Decision date (initial)
- 2023-07-05
- 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
metabolic bone diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10028395 | Musculoskeletal and connective tissue disorders | 17 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mesentech Inc.
- Sponsor organisation
- Mesentech Inc.
- Address
- 2222 Health Sciences Mall
- City
- Vancouver
- Postcode
- V6T 1Z3
- Country
- Canada
Scientific contact point
- Organisation
- Mesentech Inc.
- Contact name
- Mesentech
Public contact point
- Organisation
- Mesentech Inc.
- Contact name
- Mesentech
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 72 | 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 | 2023-08-11 | 2024-11-18 | 2023-08-11 | 2024-07-18 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-05 | Netherlands | Acceptable 2023-07-05
|
2023-07-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-31 | Netherlands | Acceptable 2023-08-30
|
2023-08-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-23 | Netherlands | Acceptable 2023-08-30
|
2023-11-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-04 | Netherlands | Acceptable 2024-09-20
|
2024-09-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-03 | Netherlands | Acceptable 2024-10-24
|
2024-10-24 |