Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
36
Countries
1
Sites
1
Asthma
Key facts
- Sponsor
- Amgen Inc.
- 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
- 1 Jul 2025 → ongoing
- Decision date (initial)
- 2025-05-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520503-27-00
- WHO UTN
- U1111-1317-0354
- ClinicalTrials.gov
- NCT06637371
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 3 | 1 |
| Rest of world
Australia, United States, United Kingdom, Canada
|
— | 33 | — |
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 |
|---|---|---|---|---|---|
| Belgium | 2025-07-01 | 2025-09-09 | 2026-05-22 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-04 | Belgium | Acceptable 2025-05-22
|
2025-05-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-12 | Belgium | Acceptable 2025-05-22
|
2025-06-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-18 | Belgium | Acceptable 2025-10-24
|
2025-10-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-13 | Belgium | Acceptable 2026-03-18
|
2026-03-18 |