Contact information
Type
Scientific
Contact name
Dr Suhail Nurbhai
ORCID ID
Contact details
Mission Therapeutics Ltd.
The Glenn Berge Building
Babraham Research Campus
Cambridge
CB22 3FH
United Kingdom
+44 (0) 1223 867926
snurbhai@missiontherapeutics.com
Type
Public
Contact name
Ms Natalie Jones
ORCID ID
Contact details
Mission Therapeutics Ltd.
The Glenn Berge Building
Babraham Research Campus
Cambridge
CB22 3FH
United Kingdom
+44 (0) 7462 135809
njones@missiontherapeutics.com
Type
Principal Investigator
Contact name
Dr Annelize Koch
ORCID ID
Contact details
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil Industrial Park
Cardiff Road
Merthyr Tydfil
CF48 4DR
United Kingdom
+44 (0)1443694313
annelize.koch@simbecorion.com
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
1008552
ClinicalTrials.gov number
Nil known
Secondary identifying numbers
MTX325-101, IRAS 1008552
Study information
Scientific title
Phase I trial code: RD 787.36057 (MTX325-101)
Acronym
Study hypothesis
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
Study design
A five-part first-in-human trial in up to 158 healthy participants and patients with mild to moderate Parkinson’s Disease
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Pharmaceutical testing facility
Study type
Safety
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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
Pharmaceutical study type(s)
Pharmacokinetic, Pharmacogenetic
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
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.
Secondary outcome measures
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.
Overall study start date
09/08/2023
Overall study end date
09/05/2026
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type(s)
Healthy volunteer, Patient
Age group
Mixed
Lower age limit
18 Years
Upper age limit
75 Years
Sex
Both
Target number of participants
158
Participant 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.
Recruitment start date
06/02/2024
Recruitment end date
14/11/2025
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
United Kingdom
Sponsor information
Organisation
Mission Therapeutics Ltd.
Sponsor details
Mission Therapeutics Ltd.
The Glenn Berge Building
Babraham Research Campus
Cambridge
CB22 3FH
England
United Kingdom
None provided
info@missiontherapeutics.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Mission Therapeutics Ltd.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 I study and the negligible benefit to the public of phase I information. Results will be posted on or after the date of publication of full trial details.
Intention to publish date
31/12/2026
Individual participant data (IPD) Intention to share
No
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.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|