Phase I Trial: Quotient code QSC206231
| ISRCTN | ISRCTN30858255 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30858255 |
| IRAS number | 1005504 |
| Secondary identifying numbers | IRAS 1005504, Quotient code: QSC206231 |
- Submission date
- 12/11/2024
- Registration date
- 22/11/2024
- Last edited
- 10/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- 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
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public
Nanomerics Ltd
2 London Wall Place
6th Floor
London
EC2Y 5AU
United Kingdom
| Phone | +44 (0)20 3397 2183 |
|---|---|
| andreas.g.schatzlein@nanomerics.com |
Scientific
Nanomerics Ltd
2 London Wall Place
6th Floor
London
EC2Y 5AU
United Kingdom
| Phone | +44 20 3397 2183 |
|---|---|
| andreas.g.schatzlein@nanomerics.com |
Study information
| Study design | Single-centre randomized study to assess safety, tolerability and pharmacokinetics in 10 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I Trial: Quotient code QSC206231 |
| 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) |
Submitted 24/07/2024, HSC REC B (ORECNI, Lissue Industrial Estate West, 5 Rathdown Walk, Lisburn, Co. Antrim, BT28 2RF, United Kingdom; +44 (0)2895361400; recb@hscni.net), ref: 24/NI/0093 |
| Condition | 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) | Pharmacokinetic |
| 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 | 24/07/2024 |
| Overall study end date | 07/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Participant inclusion criteria | Healthy 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 | 25/11/2024 |
| Recruitment end date | 07/01/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Sponsor information
Industry
2 London Wall Place
6th Floor
London
EC2Y 5AU
England
United Kingdom
| Phone | +44 (0)20 3397 2183 |
|---|---|
| andreas.g.schatzlein@nanomerics.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 07/07/2027 |
|---|---|
| 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 trail 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
10/12/2024: HRA confirmed the deferral.
12/11/2024: Study's existence confirmed by the MHRA.
