A Phase 1 trial: MEU Phase 1 Clinic: SUDO-286-102
| ISRCTN | ISRCTN10327687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10327687 |
| IRAS number | 1006866 |
- Submission date
- 05/09/2025
- Registration date
- 08/09/2025
- Last edited
- 08/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved 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
The Langley Building
Wythenshawe Hospital
Manchester
M23 9QZ
United Kingdom
| Phone | +44 (0)161 946 4050 |
|---|---|
| MKhan@meu.org.uk |
Public, Scientific
Sudo Biosciences Limited, 3rd Floor, 1 Ashley Road
Altrincham
WA14 2DT
United Kingdom
| imills@sudobio.com |
Study information
| Study design | Interventional single-centre blinded randomized study |
|---|---|
| Primary study design | Not Specified |
| Secondary study design | |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A Phase 1 trial: MEU Phase 1 Clinic: SUDO-286-102 |
| Study objectives | The Health Research Authority (HRA) has approved 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 20/06/2024, North West - Greater Manchester Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048023; gmcentral.rec@hra.nhs.uk), ref: 24/NW/0062 |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 | Other |
| Primary outcome measure | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 | 03/05/2024 |
| Completion date | 17/04/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 72 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 | 20/06/2024 |
| Date of final enrolment | 18/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
United Kingdom
Sponsor information
Industry
3rd Floor, 1 Ashley Road
Altrincham
WA14 2DT
England
United Kingdom
| clinops@sudobio.com | |
| Website | https://www.sudobio.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 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
08/09/2025: Trial's existence confirmed by North West - Greater Manchester Central Research Ethics Committee.
