Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
72
Countries
1
Sites
1
Healthy volonteers
Key facts
- Sponsor
- Lmito Therapeutics Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-11-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519180-17-00
- EudraCT number
- 2022-000044-29
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volonteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10021972 | Inflammatory bowel disease | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Lmito Therapeutics Inc.
- Sponsor organisation
- Lmito Therapeutics Inc.
- Address
- 767 Sinsu-Ro, Suji-Gu Suji-Gu
- City
- Yongin-Si
- Postcode
- 16827
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Lmito Therapeutics Inc.
- Contact name
- Eunju Lee
Public contact point
- Organisation
- Lmito Therapeutics Inc.
- Contact name
- Eunju Lee
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-28 | Netherlands | Acceptable 2024-11-25
|
2024-11-25 |