Phase I Trial: Quotient Code QSC301361
| ISRCTN | ISRCTN24628458 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24628458 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 1008762 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | IRAS 1008762, Quotient Code: QSC301361 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Stuart Mair
Principal Investigator
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 |
Mr Dennis Dean
Public, Scientific
Public, Scientific
855 Boylston Street 11th Floor
Boston, MA
02116
United States of America
| Phone | +1 617 955 6165 |
|---|---|
| Dennis@ifmthera.com |
Study information
| Study design | Three-part single-centre double-blind partially-randomized first-in-human study |
|---|---|
| Primary study design | Interventional |
| 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 setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| 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 |
| Pharmaceutical study type(s) | Not Applicable |
| 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 | 22/11/2023 |
| Completion date | 18/12/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
IFM Management, Inc
Industry
Industry
855 Boylston Street
11th Floor
Boston
MA 02116
United States of America
| Phone | +1 617 955 6165 |
|---|---|
| Dennis@ifmthera.com |
Funders
Funder type
Industry
IFM Management, Inc
No information available
Results and Publications
| Intention to publish date | 18/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The 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. Results may be posted on or after the date of publication of full trial details. |
| 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. |
Editorial Notes
25/01/2024: Ethics approval details added.
13/12/2023: Trial's existence confirmed by MHRA.
