Phase I trial: QSC303485

ISRCTN	ISRCTN33084994
DOI	https://doi.org/10.1186/ISRCTN33084994
Integrated Research Application System (IRAS)	1013141
CRO Study Code	QSC303485
Sponsor	Congruence Therapeutics Inc.
Funder	Congruence Therapeutics Inc.

Submission date: 12/02/2026
Registration date: 17/02/2026
Last edited: 17/02/2026

Recruitment status: Not yet 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 sponsor has confirmed that the trial meets the criteria for 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 Stuart Mair
Principal investigator

Mere Way, Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone	+44 (0)1159749000
Email	recruitment@weneedyou.co.uk

Dr Michael Harvey
Public, Scientific

6666 Saint-Urbain Street
Suite 450
Montreal
H2S 3H1
Canada

Phone	+1 (0)4388173666
Email	regulatory@congruencetx.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	The sponsor has confirmed that the trial meets the criteria for 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.
Purpose	Phase I study in healthy volunteers and patients
Scientific title	Phase I trial: QSC303485 (The full scientific title will be published within 30 months after the end of the trial)
Study objectives	The sponsor has confirmed that the trial meets the criteria for 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 13/02/2026, Health and Social Care Research Ethics Committee (HSC REC) B (Office for Research Ethics Committees in Northern Ireland (ORECNI), Lissue Industrial Estate West, 5 Rathdown Walk, Lisburn, BT28 2RF, United Kingdom; +44 (0)2895 361408; recb@hscni.net), ref: 26/NI/0002
Health condition(s) or problem(s) studied	The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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)	[Outcome name] measured using [metric or method of measurement] at [timepoint(s)] The sponsor has confirmed that the trial meets the criteria for 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)
Completion date	10/05/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	124
Key inclusion criteria	The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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	24/02/2026
Date of final enrolment	10/05/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Quotient Sciences Limited

Mere Way, Ruddington Fields
Ruddington
Nottingham
NG11 6JS
England

Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge Biomedical Campus, Hills Road
Cambridge
CB2 0QQ
England

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

12/02/2026: Study's existence confirmed by the MHRA.