Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Temporarily halted
Participants planned
46
Countries
1
Sites
1
Complement-mediated diseases
Key facts
- Sponsor
- Ribocure Pharmaceuticals AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 14 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-10
- 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
Complement-mediated diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ribocure Pharmaceuticals AB
- Sponsor organisation
- Ribocure Pharmaceuticals AB
- Address
- Vetenskapens Grand 11
- City
- Molndal
- Postcode
- 431 53
- Country
- Sweden
Scientific contact point
- Organisation
- Ribocure Pharmaceuticals AB
- Contact name
- Maria Liljevald
Public contact point
- Organisation
- Ribocure Pharmaceuticals AB
- Contact name
- Maria Liljevald
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Temporarily halted | 46 | 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 |
|---|---|---|---|---|---|
| Sweden | 2024-11-14 | 2024-11-14 | 2024-12-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-62495
- Halt date
- 2024-12-04
- Member states concerned
- Sweden
- Publication date
- 2024-12-11
- Reason
- Sponsor decision
- Explanation
- Based on business decisions that do not impact subject safety or benefit/risk balance.
- Follow-up measures
- No follow-up measures required as there are no active subjects, and no impact on risk benefit balance is expected.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-27 | Sweden | Acceptable 2024-09-09
|
2024-09-10 |