Phase I Trial: Quotient Code QSC301361
| ISRCTN | ISRCTN24628458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24628458 |
| ClinicalTrials.gov (NCT) | Nil Known |
| Clinical Trials Information System (CTIS) | Nil Known |
| Integrated Research Application System (IRAS) | 1008762 |
| Protocol serial number | IRAS 1008762, Quotient Code: QSC301361 |
| Sponsor | IFM Management, Inc |
| Funder | IFM Management, Inc |
- Submission date
- 08/12/2023
- Registration date
- 13/12/2023
- Last edited
- 25/01/2024
- Recruitment status
- No longer 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
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0) 330 303 1000 |
|---|---|
| Recruitment@weneedyou.co.uk |
Public, Scientific
855 Boylston Street 11th Floor
Boston, MA
02116
United States of America
| Phone | +1 617 955 6165 |
|---|---|
| Dennis@ifmthera.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Three-part single-centre double-blind partially-randomized first-in-human study |
| Secondary study design | Part 1, Part 2 Cohorts 1-4 and 6-7 and Part 3: Randomised Control Trial. Part 2 Cohort 5: Non-randomised Study |
| Study type | Participant information sheet |
| Scientific title | Phase I Trial: Quotient Code QSC301361 |
| 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 05/01/2024, HSC REC B (ORECNI, Business Services Organisation, Lissue Industrial Estate West, Lisburn, Co. Antrium, BT28 2RF, United Kingdom; +44 2895361400; RECB@hscni.net), ref: 23/NI/0154 |
| 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. The 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. 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) |
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. |
| Completion date | 18/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 127 |
| 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 | 08/03/2024 |
| Date of final enrolment | 18/12/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington Fields
Ruddington
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 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 non-therapeutic clinical trials. |
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
25/01/2024: Ethics approval details added.
13/12/2023: Trial's existence confirmed by MHRA.
