Deferred Registration - Quotient Sciences Code: QSC303945

ISRCTN	ISRCTN13718455
DOI	https://doi.org/10.1186/ISRCTN13718455
Integrated Research Application System (IRAS)	1014164
CRO study code	Quotient Sciences Code: QSC303945
Sponsor	Draig Therapeutics Ltd.
Funder	Draig Therapeutics Ltd.

Submission date: 13/08/2026
Registration date: 01/09/2026
Last edited: 09/09/2026

Recruitment status: 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

This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.

Contact information

Dr Sharan Sidhu
Principal investigator

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

Phone	+44 330 303 1000
Email	recruitment@weneedyou.co.uk

Mr Early Phase Clinical Team
Public, Scientific

Sbarc | Spark, Maindy Road
Cardiff
CF24 4HQ
United Kingdom

Phone	+44 292 002 8450
Email	info@draigtherapeutics.com

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Phase 1 study in healthy volunteers
Scientific title	Quotient Sciences code: QSC303945 [Full scientific title to be added on or before the deferral expiry date]
Study objectives	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Ethics approval(s)	Approved 07/09/2026, London - Brent REC (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8115; brent.rec@hra.nhs.uk), ref: 26/LO/0370
Health condition(s) or problem(s) studied	Healthy volunteers
Intervention	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Primary outcome measure(s)	[Outcome name] measured using [Metric or method of measurement] at [Timepoint(s)]. This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Key secondary outcome measure(s)
Completion date	16/11/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	30 Years
Upper age limit	65 Years
Sex	Male
Target sample size at registration	8
Key inclusion criteria	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Key exclusion criteria	This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Date of first enrolment	25/09/2026
Date of final enrolment	16/11/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Quotient Sciences Limited

Mere Way, Ruddington Fields
Ruddington
Nottingham
NG11 6JS
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

09/09/2026: The ethics approval was added. Combined Review approval from the MHRA and REC has now been received, dated 07 Sep 2026.
01/09/2026: Trial's existence confirmed by MHRA.