A Phase 1 trial: Fortrea Phase 1 Leeds Clinic: SUDO-550-101

ISRCTN	ISRCTN13177674
DOI	https://doi.org/10.1186/ISRCTN13177674
IRAS number	1010113
Secondary identifying numbers	8535365

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Jim Bush
Principal Investigator

Fortrea Clinical Research Unit Ltd
Drapers Yard
Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom

Phone	+44 (0) 1133013590
Email	Jim.Bush@Fortrea.com

Dr Ian Mills
Public, Scientific

Sudo Biosciences Limited, 3rd Floor, 1 Ashley Road, Altrincham
Cheshire
WA14 2DT
United Kingdom

Phone	None provided
Email	IMills@sudobio.com

Study information

Study design	Interventional single-centre partially blinded randomized study
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Other
Study type	Safety
Participant information sheet	Not available in web format, please use the contact details to request a 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	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	01/07/2024
Completion date	20/08/2025

Eligibility

Participant type(s)	Healthy volunteer, Other
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Fortrea Clinical Research Unit Limited

Draper's Yard Marshall Street
Holbeck
Leeds
LS11 9EH
United Kingdom

Sponsor information

Sudo Biosciences Limited
Industry

3rd Floor, 1 Ashley Road, Altrincham
Cheshire
WA14 2DT
England
United Kingdom

Phone	None provided
Email	clinops@sudobio.com
Website	https://www.sudobio.com/

Funders

Funder type

Industry

Sudo Biosciences Limited

No information available

Results and Publications

Intention to publish date	20/02/2028
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

26/08/2025: Study and Sponsor contacts were updated.
02/07/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)