Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
114
Countries
1
Sites
1
Malaria
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Parasitic Diseases [C03]
- Trial duration
- 7 May 2025 → ongoing
- Decision date (initial)
- 2025-04-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Malaria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10025487 | Malaria | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 114 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-05-07 | 2025-05-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-28 | Netherlands | Acceptable 2025-04-08
|
2025-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-20 | Netherlands | Acceptable 2025-07-10
|
2025-07-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-20 | Netherlands | Acceptable 2026-03-02
|
2026-03-02 |