Deferred Registration: Quotient Sciences Code: QSC303955

ISRCTN	ISRCTN16869276
DOI	https://doi.org/10.1186/ISRCTN16869276
Integrated Research Application System (IRAS)	1013771
Quotient Sciences code	QSC303955
Sponsor	Skyhawk Therapeutics, Inc.
Funder	Skyhawk Therapeutics, Inc.

Submission date: 07/05/2026
Registration date: 24/06/2026
Last edited: 24/06/2026

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 Nand Singh
Principal investigator

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

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

Skyhawk Study Doctor
Public, Scientific

180 3rd Ave. Sixth Floor
Waltham
MA 02451
United States of America

Phone	+1-(617)-858-0041
Email	brian.yoon@skyhawktx.com

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Active
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: Quotient Sciences Code: QSC303955 [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)	Submitted 27/04/2026, London – Harrow Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048357; harrow.rec@hra.nhs.uk), ref: 26/LO/0384
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	29/08/2026

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	All
Target sample size at registration	14
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	29/06/2026
Date of final enrolment	29/08/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Quotient Sciences

Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

24/06/2026: Trial's existence confirmed by MHRA.