Deferred Registration: Quotient Sciences Code: QSC302324

ISRCTN	ISRCTN13656987
DOI	https://doi.org/10.1186/ISRCTN13656987
Integrated Research Application System (IRAS)	1010387
Sponsor	Pheno Therapeutics Limited
Funder	Pheno Therapeutics Limited

Submission date: 19/05/2026
Registration date: 13/07/2026
Last edited: 13/07/2026

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) 330 303 1000
Email	recruitment@weneedyou.co.uk

Dr Clinical Trials Information
Public, Scientific

Pheno Therapeutics Limited
Citypoint, 3rd Floor
65 Haymarket Terrace
Edinburgh
EH12 5HD
United Kingdom

Email	info@phenotherapeutics.com

Study information

Primary study design	Interventional
Study design	Two-part, single centre, randomised, first-in-man study to assess safety, pharmacokinetics, pharmacodynamics and food effect in 84 healthy volunteers.
Secondary study design
Scientific title	Deferred Registration: Quotient Sciences Code: QSC302324 [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 29/10/2024, Health and Social Care Research Ethics Committee A (HSC REC A) (Lissue Industrial Estate West, 5 Rathdown Walk, Lisburn, BT28 2RF, United Kingdom; +44 2895361400; reca@hscni.net), ref: 24/NI/0088
Health condition(s) or problem(s) studied	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	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)	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)	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	20/11/2027

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	84
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	17/11/2026
Date of final enrolment	20/11/2027

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

13/07/2026: Trial's existence confirmed by MHRA.