Phase I trial: MM-120-101
| ISRCTN | ISRCTN11052603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11052603 |
| IRAS number | 1007602 |
| Secondary identifying numbers | IRAS 1007602 |
- Submission date
- 14/05/2024
- Registration date
- 21/05/2024
- Last edited
- 20/05/2024
- Recruitment status
- No longer 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 David Gregory
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
11 Tiger Court, Kings Drive Prescot
Liverpool
L34 1BH
United Kingdom
| Phone | +44 (0)151 4824700 |
|---|---|
| davidgregory@macplc.com |
Study information
| Study design | Phase 1 study in 30 healthy volunteers |
|---|---|
| Primary study design | Not Specified |
| Secondary study design | |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Phase I trial: MM-120-101 |
| 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) |
Approved 18/09/2023, Wales Research Ethics Committee 1 Cardiff (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road, East Cardiff, CF11 9AB, United Kingdom; 02922940912; wales.rec1@wales.nhs.uk), ref: 23/WA/0112 |
| Health condition(s) or problem(s) studied | Healthy volunteers |
| 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 |
| 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 | 18/04/2023 |
| Completion date | 19/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| 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 | 13/10/2023 |
| Date of final enrolment | 04/12/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
MAC Clinical Research Liverpool
11 Tiger Court
King's Business Park
Liverpool
L34 1BH
United Kingdom
King's Business Park
Liverpool
L34 1BH
United Kingdom
MAC Clinical Research Manchester
Citylabs 1.0
Nelson St
Manchester
M13 9NQ
United Kingdom
Nelson St
Manchester
M13 9NQ
United Kingdom
Sponsor information
Mind Medicine Inc
Research organisation
Research organisation
One World Trade Centre, Suite 8500
New York
NY 10007
United States of America
| Phone | +1 513 476 9666 |
|---|---|
| aengel@mindmed.co | |
| Website | https://mindmed.co/ |
Funders
Funder type
Research organisation
Mind Medicine Inc
No information available
Results and Publications
| Intention to publish date | 19/06/2026 |
|---|---|
| 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 I study. Results will be posted on or after the date of publication of full trial details. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to commercial sensitivity of the data |
Editorial Notes
15/05/2024: Study's existence confirmed by the Wales Research Ethics Committee 1 Cardiff.
