Deferred registration: Quotient Sciences code: QSC303996

ISRCTN	ISRCTN54346737
DOI	https://doi.org/10.1186/ISRCTN54346737
Integrated Research Application System (IRAS)	1013675
CRO code	QSC303996
Sponsor	Orion Corporation (Finland)
Funder	Orion Corporation

Submission date: 04/05/2026
Registration date: 18/05/2026
Last edited: 18/05/2026

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 Nand Singh
Principal investigator

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

Phone	+44 01159749000
Email	recruitment@weneedyou.co.uk

Clinical Study Director
Public, Scientific

Orionintie 1
Espoo
FI-0220
Finland

Phone	+358 10 4261
Email	clinicaltrials@orionpharma.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	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.
Purpose	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.
Scientific title	Deferred registration: Quotient Sciences code: QSC303996
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)	Submitted 17/03/2026, London – Bridge Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 0207 104 8387; londonbridge.rec@hra.nhs.uk), ref: 26/LO/0180
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	10/08/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	25 Years
Upper age limit	55 Years
Sex	Male
Target sample size at registration	44
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	15/05/2026
Date of final enrolment	10/08/2026

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

15/05/2026: Study’s existence confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA), UK.