Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
24
Countries
1
Sites
1
Hypolactasia
Key facts
- Sponsor
- Venter Pharma S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 7 Nov 2025 → ongoing
- Decision date (initial)
- 2025-07-22
- 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
Hypolactasia
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Venter Pharma S.L.
- Sponsor organisation
- Venter Pharma S.L.
- Address
- Calle De Almagro 1 Bajo Dcha 1
- City
- Madrid
- Postcode
- 28010
- Country
- Spain
Scientific contact point
- Organisation
- Venter Pharma S.L.
- Contact name
- Carmen Hermida
Public contact point
- Organisation
- Venter Pharma S.L.
- Contact name
- Carmen Hermida
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 24 | 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 |
|---|---|---|---|---|---|
| Spain | 2025-11-07 | 2025-11-13 | 2025-11-19 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-11 | Spain | Acceptable 2025-07-17
|
2025-07-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-03 | Spain | Acceptable | 2025-10-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-04 | Spain | Acceptable | 2025-11-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-07 | Spain | Acceptable | 2025-11-07 |