Phase 1 Trial: 36024 (SYX-5219-101)

ISRCTN	ISRCTN80838388
DOI	https://doi.org/10.1186/ISRCTN80838388
IRAS number	1011149
Secondary identifying numbers	SYX-5219-101

Submission date: 21/03/2025
Registration date: 21/03/2025
Last edited: 21/03/2025

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

The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.

Contact information

Dr Ravi Rao
Scientific

Sitryx Therapeutics Ltd, 101 Bellhouse Building, Magdalen Centre, Oxford Science Park
Cambridge
OX4 4GA
United Kingdom

Phone	+44 (0)1865 648401
Email	ravi.rao@sitryx.com

Mr Gordon Dingwall
Public

Sitryx Therapeutics Ltd, 101 Bellhouse Building, Magdalen Centre, Oxford Science Park
Cambridge
OX4 4GA
United Kingdom

Phone	+44 (0)1865 648401
Email	gordon.dingwall@sitryx.com

Dr Annelize Koch
Principal Investigator

Simbec-Orion Clinical Pharmacology, Merthyr Tydfil Industrial Park, Cardiff Road
Merthyr Tydfil
CF48 4DR
United Kingdom

Phone	+44 1443694313
Email	annelize.koch@simbecorion.com

Study information

Study design	A three-part first-in-human trial in up to 149 healthy participants and patients with Atopic Dermatitis (AD)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Pharmaceutical testing facility, Other
Study type	Other, Safety
Scientific title	Phase 1 Trial: 36024 (SYX-5219-101)
Study objectives	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Ethics approval(s)	1. Approved 13/02/2025, Wales Research Ethics Committee 2 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922 941119; Wales.REC2@wales.nhs.uk), ref: 25.WA.0017 2. Approved 18/02/2025, MHRA (MHRA, 10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 60473/0001/001-0001
Health condition(s) or problem(s) studied	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Intervention	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Intervention type	Drug
Pharmaceutical study type(s)	Pharmacokinetic, Pharmacodynamic
Phase	Phase I
Drug / device / biological / vaccine name(s)	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Primary outcome measure	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Secondary outcome measures	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Overall study start date	30/09/2024
Completion date	31/08/2026

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	149
Key inclusion criteria	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Key exclusion criteria	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Date of first enrolment	26/02/2025
Date of final enrolment	30/06/2026

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Simbec Research Limited

Simbec House Merthyr Tydfil Industrial Park
Merthyr Tydfil Industrial Park
Pentrebach
Merthyr Tydfil
Mid Glamorgan
CF48 4DR
United Kingdom

Sponsor information

Sitryx Therapeutics Ltd.
Industry

101 Bellhouse Building, Magdalen Centre, Oxford Science Park
Cambridge
OX4 4GA
England
United Kingdom

Email	gordon.dingwall@sitryx.com
Website	https://www.sitryx.com/

Funders

Funder type

Industry

Sitryx Therapeutics Ltd.

No information available

Results and Publications

Intention to publish date	20/12/2029
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. Results will be posted on or after the date of publication of full trial details.
IPD sharing plan	The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials.

Editorial Notes

21/03/2025: Trial's existence confirmed by Wales Research Ethics Committee 2.