Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ended
Participants planned
128
Countries
1
Sites
2
Chronic spontaneous urticaria
Key facts
- Sponsor
- Laboratorios Liomont S.A. de C.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 Feb 2025 → 5 Jan 2026
- Decision date (initial)
- 2025-01-15
- 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
Chronic spontaneous urticaria
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Laboratorios Liomont S.A. de C.V.
- Sponsor organisation
- Laboratorios Liomont S.A. de C.V.
- Address
- Calle Adolfo Lopez Mateos 68, Col. Cuajimalpa Col. Cuajimalpa
- City
- Ciudad De Mexico
- Postcode
- 05000
- Country
- Mexico
Scientific contact point
- Organisation
- Laboratorios Liomont S.A. de C.V.
- Contact name
- Livan Delgado
Public contact point
- Organisation
- Laboratorios Liomont S.A. de C.V.
- Contact name
- Livan Delgado
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 68 | 2 |
| Rest of world
Mexico
|
— | 60 | — |
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 |
|---|---|---|---|---|---|
| Spain | 2025-02-26 | 2025-11-13 | 2025-03-07 | 2025-07-09 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | Spain | Acceptable 2025-01-15
|
2025-01-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-03-05 | Spain | Acceptable 2025-01-15
|
2025-03-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-03 | Spain | Acceptable 2025-05-17
|
2025-05-17 |