Phase 1 trial HMR code: 25-006

ISRCTN	ISRCTN13906399
DOI	https://doi.org/10.1186/ISRCTN13906399
IRAS number	1012527
Secondary identifying numbers	HMR code: 25-006; sponsor code: MED-TSN-102

Submission date: 25/09/2025
Registration date: 29/09/2025
Last edited: 08/10/2025

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 sponsor has confirmed that the trial meets the criteria for 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 Takahiro Yamamoto
Principal Investigator

Hammersmith Medicines Research, Cumberland Avenue
London
NW10 7EW
United Kingdom

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

Mr John Burt
Scientific

The Venture Centre Sir William Lyons Road, University of Warwick Science Park
Coventry
CV4 7EZ
United Kingdom

Phone	+44 (0) 2476 323 060
Email	j.burt@medherant.co.uk

Ms Gemma Clark
Public

The Venture Centre Sir William Lyons Road, University of Warwick Science Park
Coventry
CV4 7EZ
United Kingdom

Phone	+44 (0) 2476 323 060
Email	g.clark@medherant.co.uk

Mr Gaidad Tekle
Scientific

The Venture Centre Sir William Lyons Road, University of Warwick Science Park
Coventry
CV4 7EZ
United Kingdom

Phone	+44 (0) 2476 323 060
Email	G.tekle@medherant.co.uk

Study information

Study design	Safety and pharmacokinetics trial in up to 36 healthy women
Primary study design	Interventional
Secondary study design	Open label
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format.
Scientific title	Phase 1 trial HMR code: 25-006 The full scientific title will be published within 30 months after the end of the trial
Study objectives	The sponsor has confirmed that the trial meets the criteria for 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)	Approved 01/09/2025, London – Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 20 7104 8128; brent.rec@hra.nhs.uk), ref: 25/LO/0462
Health condition(s) or problem(s) studied	Healthy volunteers
Intervention	The sponsor has confirmed that the trial meets the criteria for 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)	The sponsor has confirmed that the trial meets the criteria for 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.
Phase	Phase I
Drug / device / biological / vaccine name(s)	The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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	14/07/2025
Completion date	23/05/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Mixed
Sex	Female
Target number of participants	Up to 36
Key inclusion criteria	Healthy human volunteer
Key exclusion criteria	The sponsor has confirmed that the trial meets the criteria for 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	07/10/2025
Date of final enrolment	23/02/2026

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Hammersmith Medicines Research (HMR)

Cumberland Avenue, Park Royal
London
NW10 7EW
United Kingdom

Sponsor information

Medherant Limited
Industry

The Venture Centre Sir William Lyons Road, University of Warwick Science Park
Coventry
CV4 7EZ
England
United Kingdom

Phone	+44 (0) 2476 323 060
Email	g.clark@medherant.co.uk

Funders

Funder type

Industry

Medherant Limited

No information available

Results and Publications

Intention to publish date	23/11/2028
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 1 study and the negligible benefit to the public of Phase I information. Results may 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

08/10/2025: A study contact was added.
26/09/2025: Trial's existence confirmed by MHRA.