Phase 1/2a Trial: 36919 (T7-010-02)

ISRCTN	ISRCTN16811407
DOI	https://doi.org/10.1186/ISRCTN16811407
Integrated Research Application System (IRAS)	1014307
Sponsor	T7 Therapeutics Inc
Funder	T7 Therapeutics Inc

Submission date: 28/08/2026
Registration date: 28/08/2026
Last edited: 28/08/2026

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

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

Ms Cynthia Cardinal
Public, Scientific

T7 Therapeutics, Inc. 251 Little Falls Drive
Wilmington, Delaware
DE 19808
United States of America

Phone	+ 1 514-452-9046
Email	cynthia.cardinal@t7therapeutics.com

Dr Annelize Koch
Principal investigator

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

Phone	+44 (0)1443 694313
Email	annelize.koch@simbecorion.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Sequential
Purpose	Safety, Tolerability, PK and PD
Scientific title	Phase 1/2a Trial: 36919 (T7-010-02) [Full scientific title to be added on or before the deferral expiry date]
Study acronym	T7-010-02
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 14/08/2026, Wales Research Ethics Committee 2 (Health and Care Research Wales, Floor 4, Crown Building, Cathays Park, Cardiff, CF10 3NQ, United Kingdom; no telephone number provided; Wales.REC2@wales.nhs.uk), ref: 26/WA/0158 2. Approved 14/08/2026, MHRA (MHRA, 10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 62527/0001/001-0001
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
Phase	Phase I/II
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(s)	[Outcome] measured using [measure] at [timepoint]. 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 secondary outcome measure(s)
Completion date	14/07/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	194
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	08/09/2026
Date of final enrolment	13/04/2027

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Simbec-Orion Clinical Pharmacology (AKA Simbec Research Ltd)

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

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

28/08/2026: Trial's existence confirmed by Wales Research Ethics Committee 2.