Phase I Trial: Quotient Code QSC303299
| ISRCTN | ISRCTN10840798 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10840798 |
| Integrated Research Application System (IRAS) | 1013082 |
| Sponsor | Vicore Pharma (Sweden) |
| Funder | Vicore Pharma |
- Submission date
- 23/01/2026
- Registration date
- 06/02/2026
- Last edited
- 06/02/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Deferred
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Contact information
Dr Philip Evans
Principal investigator
Principal investigator
Mere Way, Ruddington Fields, Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)3303031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Dr Vicore Study Doctor
Scientific, Public
Scientific, Public
Kornhamnstorg 53
Stockholm
111 27
Sweden
| Phone | +46 (0)317880560 |
|---|---|
| karin.eklund.vanderpol@vicorepharma.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | Phase I trial in healthy volunteers | |
| Scientific title | Phase I Trial: Quotient Code QSC303299 [the full scientific title will be published within 30 months after the end of the trial] | |
| Study objectives | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. | |
| Ethics approval(s) |
Submitted 05/01/2026, London - Harrow REC (Health Research Authority, 2 Redman Place, Stratford, London, E201JQ, United Kingdom; +44 (0)2071048178; harrow.rec@hra.nhs.uk), ref: 26/LO/0005 | |
| Health condition(s) or problem(s) studied | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. | |
| Intervention | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. | |
| Intervention type | Drug | |
| Phase | Phase I | |
| Drug / device / biological / vaccine name(s) | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 22/05/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 30 Years |
| Upper age limit | 65 Years |
| Sex | Male |
| Target sample size at registration | 8 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 07/03/2026 |
| Date of final enrolment | 22/05/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
England
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
06/02/2026: Study's existence confirmed by the MHRA.
