A Phase 1 trial: Fortrea Phase 1 Leeds Clinic: SUDO-550-101
| ISRCTN | ISRCTN13177674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13177674 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1010113 |
| Protocol serial number | 8535365 |
| Sponsor | Sudo Biosciences Limited |
| Funder | Sudo Biosciences Limited |
- Submission date
- 02/07/2025
- Registration date
- 03/07/2025
- Last edited
- 26/08/2025
- 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
Fortrea Clinical Research Unit Ltd
Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom
| Phone | +44 (0) 1133013590 |
|---|---|
| Jim.Bush@Fortrea.com |
Public, Scientific
Sudo Biosciences Limited, 3rd Floor, 1 Ashley Road, Altrincham
Cheshire
WA14 2DT
United Kingdom
| Phone | None provided |
|---|---|
| IMills@sudobio.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single-centre partially blinded randomized study |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | A Phase 1 trial: Fortrea Phase 1 Leeds Clinic: SUDO-550-101 |
| 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 20/09/2024, London Chelsea Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8141; chelsea.rec@hra.nhs.uk), ref: 24/LO/0575 |
| 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 | 20/08/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Other |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 165 |
| 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 | 03/10/2024 |
| Date of final enrolment | 20/08/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Holbeck
Leeds
LS11 9EH
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
26/08/2025: Study and Sponsor contacts were updated.
02/07/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
