Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
324
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Prestige Biopharma Ltd
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 31 Mar 2022 → ongoing
- Decision date (initial)
- 2024-10-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519145-30-00
- EudraCT number
- 2021-003507-17
- ClinicalTrials.gov
- NCT05108259
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Prestige Biopharma Ltd
- Sponsor organisation
- Prestige Biopharma Ltd
- Address
- 21 Biopolis Road, #04-24 28 Nucleos South Building Biopolis #04-24 28 Nucleos South Building Biopolis
- City
- Singapore
- Postcode
- 138567
- Country
- Singapore
Scientific contact point
- Organisation
- Prestige Biopharma Ltd
- Contact name
- SOLOMON-I Clinical Trial Team
Public contact point
- Organisation
- Prestige Biopharma Ltd
- Contact name
- SOLOMON-I Clinical Trial Team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Temporarily halted | 93 | 1 |
| Rest of world
Australia
|
— | 231 | — |
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 | 2022-03-31 | 2022-03-31 | 2024-11-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-55317
- Halt date
- 2024-11-04
- Member states concerned
- Spain
- Publication date
- 2024-11-04
- Reason
- Sponsor decision
- Explanation
- Due to 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 to benefit-risk 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 | 2024-10-24 | Spain | Acceptable 2024-10-31
|
2024-10-31 |