Deferred Registration: Quotient Sciences Code: QSC303709

ISRCTN	ISRCTN10081483
DOI	https://doi.org/10.1186/ISRCTN10081483
Integrated Research Application System (IRAS)	1013851
Quotient Sciences Code	QSC303709
Sponsor	Skyhawk Therapeutics, Inc.
Funder	Skyhawk Therapeutics, Inc.

Submission date: 09/06/2026
Registration date: 30/06/2026
Last edited: 30/06/2026

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
Scientific, Public

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	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Phase I trial in healthy volunteers
Scientific title	Deferred registration: Quotient Sciences Code: QSC303709 [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 22/05/2026, London - Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8128; brent.rec@hra.nhs.uk), ref: 26/LO/0337
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)	[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.
Completion date	07/09/2026

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	03/08/2026
Date of final enrolment	07/09/2026

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

30/06/2026: Study's existence confirmed by the MHRA.