Phase I trial MM-402-101
| ISRCTN | ISRCTN13877948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13877948 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1007767 |
| Protocol serial number | IRAS 1007767 |
| Sponsor | Mind Medicine Inc. |
| Funder | Mind Medicine Inc. |
- 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
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, Principal investigator
11 Tiger Court
Kings Drive Prescot
Liverpool
L34 1BH
United Kingdom
| Phone | +44 (0)1514824700 |
|---|---|
| davidgregory@macplc.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I study in 40 healthy volunteers |
| Secondary study design | Non randomised study |
| Study type | 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 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 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 |
| 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 |
| 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 | 14/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| 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 | 10/05/2024 |
| Date of final enrolment | 30/09/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
King's Business Park
Liverpool
L34 1BH
United Kingdom
Nelson St
Manchester
M13 9NQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/05/2024: Study's existence confirmed by Wales Research Ethics Committee 1.
