Phase 1 Trial: RD 792.34234 (SPON1896-22)
| ISRCTN | ISRCTN81436702 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81436702 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2022-002562-33 |
| Integrated Research Application System (IRAS) | 1006242 |
| Protocol serial number | SPON1896-22, IRAS 1006242 |
| Sponsor | Cardiff University |
| Funder | Wellcome Trust |
- Submission date
- 23/01/2023
- Registration date
- 24/01/2023
- Last edited
- 24/01/2023
- 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
Scientific
Cardiff University
Medicines Discovery Institute
Main Building
Park Place
Cardiff
CF10 3AT
United Kingdom
| Phone | + 44 (0)2922 511 095 |
|---|---|
| swettenhamj@cardiff.ac.uk |
Public
Cardiff University
Medicines Discovery Institute
Main Building
Park Place
Cardiff
CF10 3AT
United Kingdom
| Phone | + 44 (0)2922 511 095 |
|---|---|
| swettenhamj@cardiff.ac.uk |
Principal investigator
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil Industrial Park
Cardiff Road
Merthyr Tydfil
CF48 4DR
United Kingdom
| Phone | +44 (0)1443694313 |
|---|---|
| annelize.koch@simbecorion.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A three-part first-in-human trial in up to 116 healthy participants |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase 1 Trial: RD 792.34234 (SPON1896-22) [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) | 1. Approved 06/12/2022, Wales Research Ethics Committee 1 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 230457; Wales.REC1@wales.nhs.uk), ref: 22/WA/0320 2. Approved 22/12/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 21323/0056/001-0001 The HRA has approved deferral of publication of trial details. |
| 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 | 03/11/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 116 |
| 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 | 09/01/2023 |
| Date of final enrolment | 29/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Merthyr Tydfil Industrial Park
Pentrebach
Merthyr Tydfil
Mid Glamorgan
CF48 4DR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/01/2023: Trial's existence confirmed by the MHRA.
