Phase I Study: Quotient Code QSC303294
| ISRCTN | ISRCTN16910437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16910437 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1012558 |
| Protocol serial number | Quotient Code QSC303294 |
| Sponsor | BIAL Portela & Ca. S.A. |
| Funder | BIAL Portela & Ca. S.A. |
- Submission date
- 10/11/2025
- Registration date
- 13/11/2025
- Last edited
- 13/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Deferred
- Condition category
- Not Specified
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
Principal investigator
Mere Way, Ruddington Fields, Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0) 330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public, Scientific
À Av. Siderurgia Nacional
Coronado
4745-457
Portugal
| Phone | +351 22 986 6100 |
|---|---|
| teofilo.vasconcelos@bial.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-part study to evaluate pharmacokinetics of formulations in healthy volunteers |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Phase I Study: Quotient Code QSC303294 |
| Study objectives | The sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) |
1. Approved 06/11/2025, London - Surrey Borders (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 20 7972 8143; surreyborders.rec@hra.nhs.uk), ref: 25/LO/0648 2. Approved 06/11/2025, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 21566/0225/001-0001 |
| 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) |
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 secondary outcome measure(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. |
| Completion date | 03/07/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 26 |
| Key inclusion criteria | The sponsor has confirmed that the trial meets the criteria for deferral of the publication of the full details of the trial. The 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 | 18/11/2025 |
| Date of final enrolment | 03/07/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/11/2025: Trial's existence confirmed by MHRA.
