Phase I Trial, Quotient Code: QSC300320
| ISRCTN | ISRCTN28849775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28849775 |
| EudraCT/CTIS number | 2022‐002756‐39 |
| IRAS number | 1006328 |
| Secondary identifying numbers | IRAS 1006328, Quotient Code: QSC300320 |
- Submission date
- 23/09/2022
- Registration date
- 05/10/2022
- Last edited
- 14/02/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Other
Plain English Summary
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
Quotient Sciences Limited
Mere Way
Ruddington Fields
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Scientific
Norgine House
Widewater Place
Moorhall Road
Uxbridge
UB9 6NS
United Kingdom
| Phone | +44(0)1895453584 |
|---|---|
| rng@norgine.com |
Public
Norgine House
Widewater Place
Moorhall Road
Uxbridge
UB9 6NS
United Kingdom
| Phone | +44(0)1895453736 |
|---|---|
| jpilot@norgine.com |
Study information
| Study design | Efficacy and safety trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I Trial, Quotient Code: QSC300320 [The full scientific title will be published within 30 months after the end of the trial] |
| Study hypothesis | 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 25/10/2022, South Central - Oxford A REC (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8290, (0)207 104 8206, (0)207 104 8061; oxforda.rec@hra.nhs.uk); Ref - 22/SC/0294 2. Approved 25/10/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 00322/0315/001-0001 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 23/08/2022 |
| Overall study end date | 10/01/2024 |
| Reason abandoned (if study stopped) | Other reason not related to safety |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 126 |
| Participant inclusion criteria | Healthy human volunteer |
| Participant 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. |
| Recruitment start date | 20/10/2022 |
| Recruitment end date | 26/05/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
Norgine House
Widewater Place
Moorhill Road
Uxbridge
UB9 6NS
England
United Kingdom
| Phone | +44(0)1895826600 |
|---|---|
| clinicaltrials@norgine.com | |
| Website | https://www.norgine.com |
"ROR" |
https://ror.org/046zgtw08 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 10/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this Phase I study and the negligible benefit to the public of phase I information. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of nontherapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/02/2024: The following changes have been made:
1. The overall study end date was changed from 26/05/2023 to 10/01/2024.
2. The study was terminated due to another reason not related to safety.
3. A 30-month extension of the deferral from the overall study end date has been granted.
4. The intention to publish date was changed from 26/11/2025 to 10/07/2026.
17/11/2022: Ethics approval added.
16/11/2022: Deferral confirmed by the Health Research Authority.
05/10/2022: Trial's existence confirmed by the Medical & Healthcare products Regulatory Agency (MHRA).
