Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
132
Countries
1
Sites
2
Not applicable, healthy volunteers
Key facts
- Sponsor
- Polpharma Biologics S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 27 Jan 2026 → ongoing
- Decision date (initial)
- 2025-11-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Not applicable, healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Polpharma Biologics S.A.
- Sponsor organisation
- Polpharma Biologics S.A.
- Address
- Ul. Trzy Lipy 3
- City
- Gdansk
- Postcode
- 80-172
- Country
- Poland
Scientific contact point
- Organisation
- Polpharma Biologics S.A.
- Contact name
- Agnes Rethy
Public contact point
- Organisation
- Polpharma Biologics S.A.
- Contact name
- Chantel Tu
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 132 | 2 |
| 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 |
|---|---|---|---|---|---|
| Germany | 2025-11-14 | 2025-11-18 | 2026-05-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-115488
- Halt date
- 2026-01-05
- Member states concerned
- Germany
- Publication date
- 2026-01-20
- Reason
- Sponsor decision, Medicinal Product related
- Explanation
- The trial has been temporarily halted due to quality related information requiring further assessment of the investigational medicinal product (IMP). As the assessment could not be completed within the regulatory timelines, we as the sponsor have paused the trial as a precaution. There is currently no indication of any impact on the quality of the IMP used in this study.
- Follow-up measures
- No safety concerns have been reported in participants dosed to date.
As of 20 January 2026, twelve (12) Adverse Events have been reported in four (4) out of nine (9) participants. All Adverse Events were of mild or moderate intensity. Except for one ongoing case of common cold, all events resolved within one week, either spontaneously or with paracetamol administration. No Serious Adverse Events have been reported. None of the Adverse Events are considered suggestive of local or systemic infection.
Accordingly, the Sponsor does not consider any additional follow-up measures necessary beyond those already specified in the clinical study protocol.
Screening and dosing activities will remain paused until the quality assessment is concluded and the IMP is confirmed for continued use. - Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-22 | Germany | Acceptable 2025-11-12
|
2025-11-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-03 | Germany | Acceptable 2026-03-30
|
2026-04-07 |