Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
96
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Therini Bio Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 5 Apr 2023 → 20 Jun 2025
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517955-10-00
- EudraCT number
- 2022-003831-24
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012267 | Dementia | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Therini Bio Inc.
- Sponsor organisation
- Therini Bio Inc.
- Address
- 2108 N Street Suite 4963
- City
- Sacramento
- Postcode
- 95816-5712
- Country
- United States
Scientific contact point
- Organisation
- Therini Bio Inc.
- Contact name
- Tara Nickerson
Public contact point
- Organisation
- Therini Bio Inc.
- Contact name
- Tara Nickerson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 96 | 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 | 2023-04-05 | 2025-06-20 | 2023-04-14 | 2024-07-01 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-59943
- Halt date
- 2024-11-18
- Member states concerned
- Netherlands
- Publication date
- 2024-11-27
- Reason
- Study management related
- Explanation
- Results of current study in Healthy Volunteers (HV) show linear PK and very safe and well tolerated study treatment.
Submission for Phase 1B study is planned for Q4, 2024. The dosage in the Phase 1B study in patients with fibrin (target of THN391) may go higher than in the current phase 1A study.
Keeping option open to restart HV study in case there may be a requirement to obtain data on higher doses in HVs.
After submission of the restart of the study, the recruitment will be restarted. - Follow-up measures
- n/a
- 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 | 2024-09-27 | Netherlands | Acceptable with conditions 2024-10-15
|
2024-10-15 |