Overview
Sponsor-declared trial summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses and Food Effect of Leucettinib-21 in Healthy Male Subjects, followed by an open single dose of Leucettinib-21 in Down Syndrome individuals, and patients with Alzheimer’s disease
Key facts
- Sponsor
- Eurofins Optimed, Perha Pharmaceuticals
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Jan 2024 → ongoing
- Decision date (initial)
- 2023-12-13
- 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
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses and Food Effect of Leucettinib-21 in Healthy Male Subjects, followed by an open single dose of Leucettinib-21 in Down Syndrome individuals, and patients with Alzheimer’s disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eurofins Optimed
- Sponsor organisation
- Eurofins Optimed
- Address
- 1 Rue Des Essarts
- City
- Gieres
- Postcode
- 38610
- Country
- France
Scientific contact point
- Organisation
- Eurofins Optimed
- Contact name
- Alize FARGIER
Public contact point
- Organisation
- Eurofins Optimed
- Contact name
- Alize FARGIER
Perha Pharmaceuticals
- Sponsor organisation
- Perha Pharmaceuticals
- Address
- Batiment 1, Perharidy Perharidy
- City
- Roscoff
- Postcode
- 29680
- Country
- France
Scientific contact point
- Organisation
- Perha Pharmaceuticals
- Contact name
- Laurent MEIJER
Public contact point
- Organisation
- Perha Pharmaceuticals
- Contact name
- Laurent MEIJER
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 140 | 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 |
|---|---|---|---|---|---|
| France | 2024-01-05 | 2024-01-05 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-01 | France | Acceptable 2023-12-13
|
2023-12-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-12-14 | France | Acceptable 2023-12-13
|
2023-12-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-13 | France | Acceptable 2024-04-29
|
2024-05-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-17 | France | Acceptable 2024-08-26
|
2024-08-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-04 | France | Acceptable 2024-08-26
|
2024-09-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-12 | France | Acceptable 2025-01-22
|
2025-02-12 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-05 | France | Acceptable 2025-04-23
|
2025-04-23 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-20 | France | Acceptable 2025-07-03
|
2025-07-03 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-29 | France | Acceptable 2025-10-08
|
2025-10-08 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-12-04 | France | Acceptable 2026-01-06
|
2026-01-16 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-15 | France | Acceptable 2026-01-06
|
2026-04-15 |