Phase I trial, Quotient code: QSC205601
| ISRCTN | ISRCTN10521680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10521680 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2021-000600-38 |
| Integrated Research Application System (IRAS) | 304054 |
| Protocol serial number | IRAS 304054; Quotient code: QSC205601 |
| Sponsor | Novartis (Switzerland) |
| Funder | Novartis Pharma AG |
- Submission date
- 31/01/2022
- Registration date
- 01/02/2022
- Last edited
- 01/02/2022
- Recruitment status
- No longer 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 Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended.
Contact information
Dr Stuart Mair
Public
Public
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)3303031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Dr Stuart Mair
Scientific
Scientific
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)3303031000 |
|---|---|
| recruitment@weneedyou.co.uk |
Dr Stuart Mair
Principal investigator
Principal investigator
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)1159749000 |
|---|---|
| recruitment@weneedyou.co.uk |
Study information
| Primary study design | Other |
|---|---|
| Study design | Phase I trial to assess safety, tolerability and pharmacokinetics in 116 healthy volunteers |
| Secondary study design | |
| Study type | Participant information sheet |
| Scientific title | Phase I trial, Quotient code: QSC205601 [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Ethics approval(s) | 1. Approved 24/11/2021, London Bridge Research Ethics Committee (London HRA Centre, 2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 1048202, +44 (0)207 1048124; londonbridge.rec@hra.nhs.uk), REC ref: 21/LO/0761 2. Approved 31/12/2021, MHRA (10 South Colonnade, Canary Wharf, London E14 4PU, UK; +44 (0)20 3080 6000; info@nhra.gov.uk), ref: CTA 04935/0192/001-0001 The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Primary outcome measure(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Key secondary outcome measure(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Completion date | 06/10/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 116 |
| Key inclusion criteria | Healthy human volunteer |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record when the results are published, which will be within 30 months after the trial has ended. |
| Date of first enrolment | 02/02/2022 |
| Date of final enrolment | 06/10/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Quotient Sciences
Trent House
Mere Way
Ruddington Fields Business Park
Nottingham
NG11 6JS
United Kingdom
Mere Way
Ruddington Fields Business Park
Nottingham
NG11 6JS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/02/2022: Trial's existence confirmed by London Bridge Research Ethics Committee.
