Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
56
Countries
1
Sites
1
Depression
Key facts
- Sponsor
- Lophora ApS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 5 Aug 2025 → 23 Dec 2025
- Decision date (initial)
- 2024-09-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Depression
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012378 | Depression | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lophora ApS
- Sponsor organisation
- Lophora ApS
- Address
- Gyldenlundsvej 21/1
- City
- Charlottenlund
- Postcode
- 2920
- Country
- Denmark
Scientific contact point
- Organisation
- Lophora ApS
- Contact name
- Drug Development Associate
Public contact point
- Organisation
- Lophora ApS
- Contact name
- Chief Executive Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 56 | 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 | 2025-05-07 | 2025-12-23 | 2025-05-09 | 2025-11-14 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-87615
- Halt date
- 2025-06-23
- Planned restart
- 2025-08-29
- Member states concerned
- France
- Publication date
- 2025-06-23
- Reason
- Study management related
- Explanation
- Given the prolonged half-life and delayed Tmax compared with preclinical data, the current design of the study, with PK sampling times stopping at t48h, did not make it possible to robustly capture the elimination kinetics of the compound.
Considering this PK profile identified during the cohort 1, it was decided to submit on 20 Jun 2025 an urgent safety measures (USM1/US-87471). The submission package included the Dose escalation meeting minutes and safety and PK data extracted from cohort 1 (please refer to USM1 supporting documents).
As requested by the French competent authorities after assessment of the mentionned USM, the subject inclusion of the cohort 2 was stopped on 23-JUN-2025 (and no administration performed) and a temporary halt is submitted. - Follow-up measures
- On 23-JUN-2025, the Subject inclusion for cohort 2 was stopped and subjects were discharged from the clinical unit.
A MSA will be submitted and the study will be restarted only after reception of the final decision. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | France | Acceptable 2024-09-13
|
2024-09-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-25 | France | Acceptable | 2024-10-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-03 | France | Acceptable 2025-07-17
|
2025-08-01 |