Phase I trial MM-402-101
| ISRCTN | ISRCTN13877948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13877948 |
| IRAS number | 1007767 |
| Secondary identifying numbers | IRAS 1007767 |
- Submission date
- 14/05/2024
- Registration date
- 21/05/2024
- Last edited
- 21/05/2024
- 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
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)1514824700 |
|---|---|
| davidgregory@macplc.com |
Study information
| Study design | Phase I study in 40 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| 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-402-101 [The full scientific title will be published within 30 months after the end of the trial] |
| 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) |
Approved 24/10/2023, Wales Research Ethics Committee 1 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road, Cardiff, CF11 9AB, United Kingdom; +44 (0)2922940912; wales.rec1@wales.nhs.uk), ref: 23/WA/0135 and CTA 57953/0002/001-0001 |
| Condition | 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) | Not Applicable |
| 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 | 18/07/2023 |
| Overall study end date | 14/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| 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 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 | 10/05/2024 |
| Recruitment end date | 30/09/2024 |
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.
Industry
Industry
One World Trade Center, Suite 8500
New York
NY 10007
United States of America
| Phone | +1 (0)513 476 9666 |
|---|---|
| aengel@mindmed.co |
Funders
Funder type
Industry
Mind Medicine Inc.
No information available
Results and Publications
| Intention to publish date | 14/04/2027 |
|---|---|
| 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 the commercial sensitivity of the data |
Editorial Notes
15/05/2024: Study's existence confirmed by Wales Research Ethics Committee 1.
