Phase I Trial: Sponsor code: X11-201-00001
| ISRCTN | ISRCTN50440735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50440735 |
| IRAS number | 1009721 |
| Secondary identifying numbers | Sponsor code: X11-201-00001 |
- Submission date
- 28/03/2025
- Registration date
- 31/03/2025
- Last edited
- 31/03/2025
- Recruitment status
- 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
MAC Clinical Research , Early Phase Suite Neuroscience Centre of Excellence Citilabs 1.0, Nelson Street
Manchester
M13, 9NQ
United Kingdom
| Phone | +44 (0) 161 274 1603 |
|---|---|
| ashleybrooks@macplc.com |
Public, Scientific
MAC Clinical Research Centre 11 Tiger Court King's Drive King's Business Park Prescot
Merseyside
L34 1BH
United Kingdom
| Phone | +44 (0) 151 482 4700 |
|---|---|
| neelbhatt@macplc.com |
Study information
| Study design | Phase 1a/b Randomized double blinded placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other, Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase I Trial: Sponsor code: X11-201-00001 |
| 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) |
Approved 11/03/2025, Wales Research Ethics Committee 1 Cardiff (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922940912; wales.rec1@wales.nhs.uk), ref: 25/WA/0026 |
| 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) | Biological/vaccine |
| 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 | 21/01/2025 |
| Overall study end date | 10/06/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 72 |
| Participant 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. |
| 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 | 27/03/2025 |
| Recruitment end date | 11/06/2026 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
Manchester, Greater Manchester
M13 9NQ
United Kingdom
Prescot, Merseyside
L34 1BH
United Kingdom
Sponsor information
Industry
2440 Research Boulevard
Rockville, Maryland
20850
United States of America
| Phone | +1 844-687-8522 |
|---|---|
| Otsuka-ProfessionalServices@otsuka-us.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 14/01/2029 |
|---|---|
| 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 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 during 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
31/03/2025: Trial's existence confirmed by MHRA.
