Phase I trial BDD code: BDD22320
| ISRCTN | ISRCTN17405388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17405388 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1009022 |
| Protocol serial number | MOS118-101 |
| Sponsor | Mosanna Therapeutics |
| Funder | Mosanna Therapeutics |
- Submission date
- 24/07/2025
- Registration date
- 24/07/2025
- Last edited
- 24/07/2025
- 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 12 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 | 0141 552 8791 |
| Lyn.Corry@bddpharma.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacoscintigraphic open-label crossover study |
| Secondary study design | Non randomised study |
| Scientific title | Phase I trial BDD code: BDD22320 |
| 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 12 months after the trial has ended. |
| Ethics approval(s) |
Approved 04/03/2024, London - Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048128; brent.rec@hra.nhs.uk), ref: 24/LO/0003 |
| 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 12 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 12 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 12 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 12 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 12 months after the trial has ended. |
| Completion date | 18/08/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 8 |
| 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 12 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 12 months after the trial has ended. |
| Date of first enrolment | 09/06/2025 |
| Date of final enrolment | 23/06/2025 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
84 Castle Street
Glasgow
G4 0SF
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 and/or analysed during the 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
24/07/2025: Study's existence confirmed by Health Research Authority (HRA) (UK).
