Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
116
Countries
1
Sites
3
mild to moderate asthma
Key facts
- Sponsor
- Generate Biomedicines Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 1 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-09
- 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
mild to moderate asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10010952 | COPD | 10038738 |
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Generate Biomedicines Inc.
- Sponsor organisation
- Generate Biomedicines Inc.
- Address
- 101 South Street Suite 900
- City
- Somerville
- Postcode
- 02143-4270
- Country
- United States
Scientific contact point
- Organisation
- Generate Biomedicines Inc.
- Contact name
- [email protected]
Public contact point
- Organisation
- Generate Biomedicines Inc.
- Contact name
- [email protected]
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 70 | 3 |
| Rest of world
United Kingdom
|
— | 46 | — |
Investigational sites
IKF Pneumologie GmbH & Co. KG
IKF Pneumologie GmbH & Co. KG, Stresemannallee 3, Sachsenhausen, Frankfurt Am Main
Charite Research Organisation GmbH
N/A, Chariteplatz 1, Mitte, Berlin
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM, Nikolai-Fuchs-Strasse 1, Gross Buchholz, Hanover
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 | 2024-03-01 | 2024-03-19 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-14 | Germany | Acceptable 2024-02-09
|
2024-02-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-16 | Germany | Acceptable 2024-02-09
|
2024-02-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-29 | Germany | Acceptable | 2024-03-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-10 | Germany | Acceptable 2024-06-05
|
2024-06-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-27 | Germany | Acceptable 2024-10-21
|
2024-11-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-13 | Germany | Acceptable 2025-03-06
|
2025-03-07 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-03 | Germany | Acceptable 2025-03-06
|
2025-04-03 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-05-20 | Germany | Acceptable 2025-03-06
|
2025-05-20 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-20 | Germany | Acceptable 2025-09-04
|
2025-09-04 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-01-20 | Germany | Acceptable 2026-02-02
|
2026-02-06 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-02-25 | Germany | Acceptable 2026-02-02
|
2026-02-25 |