Phase 1 trial: Fortrea CRU code: 8526072

ISRCTN	ISRCTN60181900
DOI	https://doi.org/10.1186/ISRCTN60181900
IRAS number	1009878

Submission date: 04/08/2025
Registration date: 04/08/2025
Last edited: 04/08/2025

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

Drapers Yard
Leeds
LS11 9EH
United Kingdom

Phone	+44 113 394 5200
Email	jim.bush@fortrea.com

Dr . Project Management Department
Public, Scientific

Chesterford Research Park
Cambridge
CB10 1XL
United Kingdom

Phone	+44 1799 531130
Email	clinical@cellcentric.com

Study information

Study design	Interventional
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Other
Scientific title	Phase 1 trial: Fortrea CRU code: 8526072
Study acronym	Nil known
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 30/10/2024, North East REC – York (2 Redman Place, London, E20 1JQ, United Kingdom; +44 207 104 8052; york.rec@hra.nhs.uk), ref: 24/NE/0157
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	23/12/2023
Completion date	02/03/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target number of participants	8
Key inclusion criteria	Healthy human volunteer
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	29/01/2025
Date of final enrolment	04/02/2025

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

CellCentric Limited
Industry

Chesterford Research Park
Cambridge
CB10 1XL
England
United Kingdom

Phone	+44 1799 531130
Email	regulatory@cellcentric.com

Funders

Funder type

Industry

CellCentric Limited

No information available

Results and Publications

Intention to publish date	02/03/2026
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 will 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 publication of results of non-therapeutic clinical trials.

Editorial Notes

04/08/2025: Trial's existence confirmed by North East REC – York.