Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
9
Countries
1
Sites
1
Respiratory viral disease
Key facts
- Sponsor
- NextCell Pharma AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2024-11-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519391-11-00
- EudraCT number
- 2020-002078-29
- ClinicalTrials.gov
- NCT04896853
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Respiratory viral disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10067384 | Respiratory syncytial virus pneumonitis | 10021881 |
| 24.0 | LLT | 10070436 | H5N1 influenza | 10021881 |
| 23.0 | PT | 10084268 | COVID-19 | 100000004862 |
| 20.0 | PT | 10066226 | Metapneumovirus infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
NextCell Pharma AB
- Sponsor organisation
- NextCell Pharma AB
- Address
- Halsovagen 7, Flemingsberg Flemingsberg
- City
- Huddinge
- Postcode
- 141 57
- Country
- Sweden
Scientific contact point
- Organisation
- NextCell Pharma AB
- Contact name
- Sofia Sisay
Public contact point
- Organisation
- NextCell Pharma AB
- Contact name
- Sofia Sisay
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 9 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-30 | Sweden | Acceptable 2024-11-27
|
2024-11-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | Sweden | Not acceptable 2025-03-31
|
2025-04-04 |