A Phase 1 trial: MEU Phase 1 Clinic: SUDO-286-102
| ISRCTN | ISRCTN10327687 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10327687 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1006866 |
| Protocol serial number | Nil known |
| Sponsor | Sudo Biosciences |
| Funder | Sudo Biosciences |
- 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
| Primary study design | Other |
|---|---|
| Study design | Interventional single-centre blinded randomized study |
| Secondary study design | |
| Study type | 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(s) |
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 secondary outcome measure(s) |
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. |
| Completion date | 17/04/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
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
08/09/2025: Trial's existence confirmed by North West - Greater Manchester Central Research Ethics Committee.
