Deferred registration: HMR code: 25-008

ISRCTN	ISRCTN11686899
DOI	https://doi.org/10.1186/ISRCTN11686899
Integrated Research Application System (IRAS)	1012821
Sponsor Protocol Code	OT-003-P1-001
Sponsor	OnTrack Therapeutics Limited (a wholly owned subsidiary of Pangea Botanica Ltd [trading as Pangea Bio])
Funder	Pangea Botanica Ltd [trading as Pangea Bio])

Submission date: 09/07/2026
Registration date: 15/07/2026
Last edited: 15/07/2026

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 Thomas Pfeiffer
Public, Scientific

1st Floor, One Suffolk Way, Sevenoaks
Kent
TN13 1YL
United Kingdom

ORCID ID	0000-0002-0571-4139
Email	info@ontrack.health

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) 2089614130
Email	rec@hmrlondon.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Phase I trial in healthy participants
Scientific title	Deferred registration: HMR code: 25-008 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 01/12/2025, North East - York Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44(0) 207 104 8079; york.rec@hra.nhs.uk), ref: 25/NE/0163
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] measured using [measure] at [timepoint]. 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	23/09/2027

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	All
Target sample size at registration	136
Key inclusion criteria	Healthy human volunteer
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	21/07/2026
Date of final enrolment	31/05/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hammersmith Medicines Research

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

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