Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
112
Countries
1
Sites
1
Idiopathic Pulmonary Fibrosis
Key facts
- Sponsor
- The Scripps Research Institute
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 14 Aug 2024 → ongoing
- Decision date (initial)
- 2024-04-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Idiopathic Pulmonary Fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
The Scripps Research Institute
- Sponsor organisation
- The Scripps Research Institute
- Address
- 11119 North Torrey Pines Road
- City
- La Jolla
- Postcode
- 92037-1046
- Country
- United States
Scientific contact point
- Organisation
- The Scripps Research Institute
- Contact name
- Alex Brooks
Public contact point
- Organisation
- The Scripps Research Institute
- Contact name
- Alex Brooks
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 112 | 1 |
| 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 |
|---|---|---|---|---|---|
| Germany | 2024-08-14 | 2024-08-19 | 2026-05-05 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-17 | Germany | Acceptable 2024-03-11
|
2024-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-03 | Germany | Acceptable | 2024-06-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-03 | Germany | Acceptable 2024-07-24
|
2024-07-31 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-07 | Germany | Acceptable 2024-07-24
|
2025-02-07 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-02 | Germany | Acceptable 2024-07-24
|
2025-04-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-08 | Germany | Acceptable 2025-10-21
|
2025-10-22 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-08 | Germany | Acceptable 2025-10-21
|
2026-05-08 |