Phase I Trial: 36414 (SUDO-550-102)
| ISRCTN | ISRCTN16822084 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16822084 |
| Sponsor | Sudo Biosciences Ltd |
| Funder | Sudo Biosciences Ltd |
- Submission date
- 16/01/2026
- Registration date
- 16/01/2026
- Last edited
- 16/01/2026
- Recruitment status
- 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
Public, Scientific
Sudo Biosciences Limited, 3rd Floor, 1 Ashley Road, Altrincham
Cheshire
WA14 2DT
United Kingdom
| Phone | N/A |
|---|---|
| IMills@sudobio.com |
Principal investigator
Simbec-Orion Clinical Pharmacology, Merthyr Tydfil Industrial Park, Cardiff Road
Merthyr Tydfil
CF48 4DR
United Kingdom
| Phone | N/A |
|---|---|
| annelize.koch@simbecorion.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | N/A: single arm study | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Single | |
| Purpose | 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. | |
| Scientific title | Phase I Trial: 36414 (SUDO-550-102) | |
| 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) |
1. Approved 20/11/2025, Wales Research Ethics Committee 2 (Health and Care Research Wales, Floor 4, Crown Building, Cathays Park, Cardiff, CF10 3NQ, United Kingdom; N/A; Wales.REC2@wales.nhs.uk), ref: 25/WA/0247 2. Approved 01/12/2025, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; N/A; info@mhra.gov.uk), ref: CTA 59625/0003/001-0001 | |
| Health condition(s) or problem(s) studied | N/A - healthy volunteers | |
| 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 | Drug | |
| Phase | Phase I | |
| Drug / device / biological / vaccine name(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. | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 09/03/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Female |
| Target sample size at registration | 22 |
| 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 | 08/12/2025 |
| Date of final enrolment | 08/02/2026 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Merthyr Tydfil
CF48 4DR
Wales
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
16/01/2026: Study's existence confirmed by Wales Research Ethics Committee 2.
