Pilot phase I, safety and pharmacokinetic study in healthy participants
| ISRCTN | ISRCTN12265152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12265152 |
| Integrated Research Application System (IRAS) | 1012318 |
| Sponsor | Mexichem UK Ltd |
| Funder | Mexichem UK Ltd |
- Submission date
- 18/11/2025
- Registration date
- 18/11/2025
- Last edited
- 18/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Public, Scientific
Heath Technical Business Park
Runcorn
WA7 4QX
United Kingdom
| Phone | +44 (0)1928518856 |
|---|---|
| james.murray@orbia.com |
Principal investigator
Medicines Evaluation Unit
Langley Building, Southmoor Road
Manchester
M23 9QZ
United Kingdom
| Phone | +44 (0)161 946 4050 |
|---|---|
| cbaxter@meu.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot Phase I, safety and pharmacokinetic study in healthy participants |
| Secondary study design | Open-label study |
| Scientific title | Pilot phase I, safety and pharmacokinetic study in healthy participants |
| Study acronym | KZ-01 |
| 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) |
Approved 22/09/2025, North West - Greater Manchester Central Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom; N/A; gmcentral.rec@hra.nhs.uk), ref: 25/NW/0216 |
| 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 | 31/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 12 |
| Total final enrolment | 12 |
| 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 | 01/10/2025 |
| Date of final enrolment | 05/11/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
18/11/2025: Study's existence confirmed by the North West - Greater Manchester Central Research Ethics Committee.
