Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
36
Countries
2
Sites
3
Solid Tumors
Key facts
- Sponsor
- Pasithea Therapeutics Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 22 Nov 2024 → ongoing
- Decision date (initial)
- 2024-06-24
- 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
Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10025648 | Malignant mast cell tumors unspecified site extranodal and solid organ sites | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pasithea Therapeutics Corp.
- Sponsor organisation
- Pasithea Therapeutics Corp.
- Address
- 1111 Lincoln Road Suite 500
- City
- Miami Beach
- Postcode
- 33139-2439
- Country
- United States
Scientific contact point
- Organisation
- Pasithea Therapeutics Corp.
- Contact name
- Tiago Reis Marques
Public contact point
- Organisation
- Pasithea Therapeutics Corp.
- Contact name
- Tiago Reis Marques
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 8 | 1 |
| Romania | Ongoing, recruiting | 16 | 2 |
| Rest of world
United States
|
— | 12 | — |
Investigational sites
Multiprofile Hospital for Active Treatment Sveta Sofia
Oncology, Bulevard Bilgariya 104, 1404, Sofiya
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Medical Oncology II, Radiotherapy I, Soseaua Fundeni 252, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Radiotherapy, Strada Republicii 34-36, 400015, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-01-08 | 2025-01-08 | |||
| Romania | 2024-11-22 | 2024-11-22 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-27 | Romania | Acceptable 2024-06-17
|
2024-06-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-28 | Romania | Acceptable 2024-10-14
|
2024-10-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-12 | Romania | Acceptable 2024-06-17
|
2024-12-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-16 | Romania | Acceptable 2024-06-17
|
2025-01-16 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-06 | Romania | Acceptable 2024-06-17
|
2025-03-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-04 | Romania | No conclusion 2025-06-11
|
2025-06-13 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-08-20 | Romania | No conclusion 2025-06-11
|
2025-08-20 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-12-05 | No conclusion 2025-06-11
|
2025-12-05 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-01-12 | Romania | No conclusion 2025-06-11
|
2026-01-12 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-03-05 | Romania | No conclusion 2025-06-11
|
2026-03-05 |