Phase I trial: BDD code: BDD23342
| ISRCTN | ISRCTN52183349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52183349 |
| IRAS number | 1009998 |
| ClinicalTrials.gov number | NCT06728176 |
| Secondary identifying numbers | BDD23342/SCZ103 |
- Submission date
- 05/02/2025
- Registration date
- 07/02/2025
- Last edited
- 19/02/2025
- 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, Principal Investigator
BDD Pharma Ltd
Within Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom
 ORCID ID |
0009-0008-4224-4667 |
|---|---|
| Phone | +44 141 552 8791 |
| lyn.corry@bddpharma.com |
Study information
| Study design | Randomized double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Pharmaceutical testing facility |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Phase I trial: BDD code: BDD23342 |
| 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 06/11/2024, London - Chelsea Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048181; chelsea.rec@hra.nhs.uk), ref: 24/LO/0703 |
| 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 |
| Pharmaceutical study type(s) | Pharmacokinetic, Dose response |
| 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 | 06/11/2024 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | up to 76 |
| 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 | 25/11/2024 |
| Date of final enrolment | 15/04/2025 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Sponsor information
Industry
Alderley Park
Congleton Road
Macclesfield
SK10 4TG
England
United Kingdom
| Phone | +44 (0)7539430768 |
|---|---|
| info@monumenttx.com | |
| Website | https://monumenttx.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 16/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 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. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. |
Editorial Notes
19/02/2025: The following amendments were made:
1. The overall study end date was changed from 16/03/2025 to 30/06/2025.
2. The target number of participants was changed from 38 to up to 76.
3. The recruitment end date was changed from 03/03/2025 to 15/04/2025.
05/02/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
