Phase I trial code: RD 787.36057 (MTX325-101)

ISRCTN	ISRCTN20898392
DOI	https://doi.org/10.1186/ISRCTN20898392
Clinical Trials Information System (CTIS)	2024-517310-15
Integrated Research Application System (IRAS)	1008552
Protocol serial number	MTX325-101
Sponsor	Mission Therapeutics Ltd.
Funder	Mission Therapeutics Ltd.

Submission date: 05/03/2024
Registration date: 06/03/2024
Last edited: 04/06/2026

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 Suhail Nurbhai
Scientific

c/o Ensors Chartered Accountants, Victory House Vision Park, Chivers Way
Histon
CB24 9ZR
United Kingdom

Phone	+44 (0) 1223 867926
Email	snurbhai@missiontherapeutics.com

Ms Sarah Fritchley
Public

c/o Ensors Chartered Accountants, Victory House Vision Park, Chivers Way
Histon
CB24 9ZR
United Kingdom

Phone	+44 (0) 7462 135809
Email	sfritchley@missiontherapeutics.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)1443694313
Email	annelize.koch@simbecorion.com

Ms Francesca Pinocci
Public

c/o Ensors Chartered Accountants, Victory House Vision Park, Chivers Way
Histon
CB24 9ZR
United Kingdom

Phone	+44 7711237599
Email	fpinocci@missiontherapuetics.com

Study information

Primary study design	Interventional
Study design	A five-part first-in-human trial in up to 158 healthy participants and patients with mild to moderate Parkinson’s Disease
Secondary study design	Randomised controlled trial
Scientific title	Phase I trial code: RD 787.36057 (MTX325-101)
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 21/11/2023, Wales Research Ethics Committee 2, Health and Care Research Wales (Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2922 941119; Wales.REC2@wales.nhs.uk), ref: 23/WA/0258 2. Approved 30/11/2023, MHRA (MHRA, 10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 56125/0002/001-0001
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
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)	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)	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.
Completion date	17/09/2027

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	158
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	06/02/2024
Date of final enrolment	16/07/2027

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
Wales

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

04/06/2026: Contact details updated.
03/06/2026: The following changes were made to the study record:
1. Contact details updated.
2. The Completion date was changed from 09/05/2026 to 17/09/2027.
3. The Date of final enrolment was changed from 14/11/2025 to 16/07/2027.
01/06/2026: A study contact was updated.
06/02/2025: The EudraCT number was added.
05/03/2024: Study's existence confirmed by the Wales Research Ethics Committee 2, Health and Care Research Wales.