Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
72
Countries
1
Sites
1
Neurodevelopmental disorder
Key facts
- Sponsor
- Iama Therapeutics S.r.l.
- 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 2024 → 10 Oct 2024
- Decision date (initial)
- 2023-12-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507454-33-00
- ClinicalTrials.gov
- NCT06300398
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Neurodevelopmental disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10064062 | Neurodevelopmental disorder | 100000004873 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Iama Therapeutics S.r.l.
- Sponsor organisation
- Iama Therapeutics S.r.l.
- Address
- Via Filippo Turati 2/9
- City
- Genoa
- Postcode
- 16128
- Country
- Italy
Scientific contact point
- Organisation
- Iama Therapeutics S.r.l.
- Contact name
- Fernanda MANHAES
Public contact point
- Organisation
- Iama Therapeutics S.r.l.
- Contact name
- Ciro SPEDALIERE
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 72 | 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 |
|---|---|---|---|---|---|
| Italy | 2024-01-08 | 2024-10-10 | 2024-01-09 | 2024-09-12 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-05 | Italy | Acceptable 2023-12-18
|
2023-12-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-02 | Italy | Acceptable 2024-06-25
|
2024-06-27 |