Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
15
Countries
2
Sites
2
Adults with Primary Ciliary Dyskinesia
Key facts
- Sponsor
- Recode Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 18 Oct 2024 → 8 Jan 2026
- Decision date (initial)
- 2024-05-28
- 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
Adults with Primary Ciliary Dyskinesia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10069713 | Primary ciliary dyskinesia | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Recode Therapeutics Inc.
- Sponsor organisation
- Recode Therapeutics Inc.
- Address
- 1455 Adams Drive Suite 1120
- City
- Menlo Park
- Postcode
- 94025-1438
- Country
- United States
Scientific contact point
- Organisation
- Recode Therapeutics Inc.
- Contact name
- Clinical Development
Public contact point
- Organisation
- Recode Therapeutics Inc.
- Contact name
- Clinical Development
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 6 | 1 |
| Germany | Ended | 6 | 1 |
| Rest of world
United States
|
— | 3 | — |
Investigational sites
Rigshospitalet
Pediatric Pulmonary Service, Blegdamsvej 9, 2100, Copenhagen Oe
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 |
|---|---|---|---|---|---|
| Denmark | 2024-10-18 | 2025-07-09 | 2024-10-22 | 2025-04-07 | |
| Germany | 2024-11-08 | 2025-09-19 | 2024-12-02 | 2025-04-07 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-13 | Denmark | Acceptable 2024-05-28
|
2024-05-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-22 | Denmark | Acceptable 2024-09-30
|
2024-09-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-13 | Denmark | Acceptable 2025-01-17
|
2025-01-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-19 | Denmark | Acceptable 2025-05-15
|
2025-05-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-19 | Acceptable 2025-10-02
|
2025-10-07 |