HMR code: 25-018

ISRCTN	ISRCTN25916618
DOI	https://doi.org/10.1186/ISRCTN25916618
Integrated Research Application System (IRAS)	1013877
CRO trial code	25-018
Sponsor	Silence Therapeutics (United Kingdom)
Funder	Silence Therapeutics

Submission date: 24/06/2026
Registration date: 29/06/2026
Last edited: 29/06/2026

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

Global Regulatory
Public, Scientific

Silence Therapeutics Plc., 12 Hammersmith Grove
London
W6 7AP
United Kingdom

Phone	N/A
Email	global-regulatory@silence-therapeutics.com

Dr Takahiro Yamamoto
Principal investigator

Hammersmith Medicines Research (HMR), Cumberland Avenue, Park Royal
London
NW10 7EW
United Kingdom

ORCID ID	0000-0001-9121-0836
Phone	+44 (0)20 8961 4130
Email	rec@hmrlondon.com

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Phase I trial in healthy participants
Scientific title	HMR code: 25-018 [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 18/06/2026, London – Harrow Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8345; harrow.rec@hra.nhs.uk), ref: 26/LO/0232
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)	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	16/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	30
Key inclusion criteria	Healthy human volunteers
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	01/07/2026
Date of final enrolment	21/07/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hammersmith Medicines Research (HMR)

Cumberland Avenue, Park Royal
London
NW10 7EW
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

26/06/2026: Study’s existence confirmed by the MHRA, UK.