A Phase 1 trial: MEU Phase 1 Clinic: SUDO-286-102

ISRCTN	ISRCTN10327687
DOI	https://doi.org/10.1186/ISRCTN10327687
Integrated Research Application System (IRAS)	1006866
Sponsor	Sudo Biosciences
Funder	Sudo Biosciences

Submission date: 05/09/2025
Registration date: 08/09/2025
Last edited: 27/04/2026

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 Naimat Khan
Principal investigator

The Langley Building
Wythenshawe Hospital
Manchester
M23 9QZ
United Kingdom

Phone	+44 (0)161 946 4050
Email	MKhan@meu.org.uk

Dr Ian Mills
Public, Scientific

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

Email	imills@sudobio.com

Study information

Primary study design	Other
Study design	Interventional single-centre blinded randomized study
Secondary study design	Not applicable
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

Medicines Evaluation Unit Limited

The Langley Building
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

27/04/2026: Internal review.
08/09/2025: Trial's existence confirmed by North West - Greater Manchester Central Research Ethics Committee.