Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
69
Countries
1
Sites
1
Healthy
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Jan 2025 → 20 Sep 2025
- Decision date (initial)
- 2023-08-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504838-21-00
- ClinicalTrials.gov
- NCT06007638
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10053643 | Neurodegenerative disorder | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 69 | 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 | 2023-08-23 | 2025-09-20 | 2023-08-23 | 2025-03-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-80966
- Halt date
- 2025-04-21
- Member states concerned
- Netherlands
- Publication date
- 2025-05-05
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Criteria for temporary halt was met on 21 April 2025 following SAE per protocol section 6.6.2. The temporary halt allows for a thorough safety evaluation and consideration of any necessary risk mitigators before resuming the study.
- Follow-up measures
- Participants continue to attend ambulatory visits as planned per protocol.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-63344
- Halt date
- 2024-12-11
- Planned restart
- 2025-01-08
- Member states concerned
- Netherlands
- Publication date
- 2024-12-16
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- Criteria for temporary halt was met on 11 December 2024 following symptoms of infusion related reactions (IRR) per protocol section 6.6.2. The temporary halt allows for a thorough safety evaluation and consideration of any necessary risk mitigators before resuming the study.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-26 | Netherlands | Acceptable 2023-08-08
|
2023-08-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-05 | Netherlands | Acceptable 2023-08-08
|
2024-01-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-28 | Netherlands | Acceptable 2024-06-21
|
2024-06-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-06 | Netherlands | Acceptable | 2024-10-01 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-20 | Netherlands | Acceptable 2025-01-07
|
2025-01-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-06 | Netherlands | Acceptable 2025-06-12
|
2025-06-13 |