Deferred registration - Phase I trial - Quotient Sciences code: QSC303633

ISRCTN	ISRCTN87347617
DOI	https://doi.org/10.1186/ISRCTN87347617
Integrated Research Application System (IRAS)	1013723
Sponsor	Alkermes, Inc
Funder	Alkermes, Inc

Submission date: 22/05/2026
Registration date: 29/05/2026
Last edited: 29/05/2026

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

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

Quotient Sciences Limited, Mere Way, Ruddington Fields, Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone	+44 (0)3303031000
Email	recruitment@weneedyou.co.uk

Director Global Clinical Services
Scientific, Public

900 Winter Street
Waltham
MA 02451
United States of America

Phone	+15715992702
Email	clinicaltrials@alkermes.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Dose comparison
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	Phase I trial in healthy volunteers
Scientific title	Deferred registration - Phase I trial - Quotient Code: QSC303633 [The full scientific title will 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)	Submitted 10/04/2026, London – Brent Research Ethics Committee (REC) (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048128; brent.rec@hra.nhs.uk), ref: 26/LO/0199
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	05/12/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	All
Target sample size at registration	51
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	18/06/2026
Date of final enrolment	05/12/2026

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

29/05/2026: Trial's existence confirmed by MHRA.