Phase I trial, Quotient Code: QSC300414
| ISRCTN | ISRCTN85847953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85847953 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1007622 |
| Protocol serial number | IRAS 1007622, Quotient Code: QSC300414 |
| Sponsor | D. E. Shaw Research |
| Funder | D. E. Shaw Research |
- Submission date
- 05/05/2023
- Registration date
- 09/05/2023
- Last edited
- 09/05/2023
- 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 |
Scientific
120 West 45th Street
39th Floor
New York
NY 10036
United States of America
| Phone | +1 (0) 212 849 0880 |
|---|---|
| Fabrizio.Giordanetto@DEShawResearch.com |
Public
120 West 45th Street
39th Floor
New York
NY 10036
United States of America
| Phone | +1 (0) 212 849 0880 |
|---|---|
| Fabrizio.Giordanetto@DEShawResearch.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-part single-center double-blind randomiZed study to assess PK, safety and tolerability in 104 healthy volunteers |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial, Quotient Code: QSC300414 [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) | 1. Submitted 18/04/2023, HSC REC B (ORECNI, Business Services Organisation, Lissue Industrial Estate West, Lisburn, Co. Antrim BT28 2RF, Northern Ireland, UK; +44 (0)28 9536 1400; recb@hscni.net), ref: 23/NI/0043 2. Submitted 18/04/2023, MHRA (10 South Colonnade, Canary Wharf, London E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 57954/0001/001-0001 |
| 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 | 24/03/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 104 |
| 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 tot he study record within 30 months after the trial has ended. |
| Date of first enrolment | 27/06/2023 |
| Date of final enrolment | 14/03/2024 |
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
09/05/2023: Trial's existence confirmed by the MHRA.
