Phase I Study (QSC303441)
| ISRCTN | ISRCTN75963665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75963665 |
| Integrated Research Application System (IRAS) | 1012643 |
| CRO study code | QSC303441 |
| Sponsor | Novartis Pharmaceuticals UK Ltd. |
| Funder | Novartis Pharmaceuticals UK Limited |
- Submission date
- 12/12/2025
- Registration date
- 23/12/2025
- Last edited
- 23/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Other
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. The 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 1159749000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public, Scientific
Lichtstrasse 35
Basel
4056
Switzerland
| Phone | +41 61 324 11 11 |
|---|---|
| novartis.email@novartis.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | 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. | |
| Purpose | Phase 1 study in healthy volunteers | |
| Scientific title | Phase I Study (QSC303441) 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. The full details will be added to the study record within 30 months after the trial has ended. | |
| Ethics approval(s) |
Approved 08/12/2025, HSC REC B (Office for Research Ethics Committees in Northern Ireland (ORECNI), Lissue Industrial Estate West 5 Rathdown Walk, Lisburn, BT28 2RF, United Kingdom; +44 28 9536 1408; RECB@hscni.net), ref: 25-NI-0144 | |
| Health condition(s) or problem(s) studied | Healthy volunteers | |
| Intervention | 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. | |
| 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. The 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. The full details will be added to the study record within 30 months after the trial has ended. | |
| Key secondary outcome measure(s) | ||
| Completion date | 12/06/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 102 |
| Key inclusion criteria | 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. |
| Key exclusion criteria | 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. |
| Date of first enrolment | 23/12/2025 |
| Date of final enrolment | 12/06/2027 |
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 |
Editorial Notes
17/12/2025: Trial's existence confirmed by MHRA.
