Phase 1 Trial: CA38132
| ISRCTN | ISRCTN67246142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67246142 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1006689 |
| Protocol serial number | IRAS 1006689, CA38132 |
| Sponsor | Pliant (United States) |
| Funder | Pliant Therapeutics Inc. |
- Submission date
- 13/04/2024
- Registration date
- 15/04/2024
- Last edited
- 15/04/2024
- 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
22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom
 ORCID ID |
0000-0001-7772-7724 |
|---|---|
| Phone | +442890 554040 |
| nadine.abdullah@celerion.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase 1 Safety Study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase 1 Trial: CA38132 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 21/03/2023, London - London Bridge Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048387; londonbridge.rec@hra.nhs.uk), ref: 22/LO/0842 2. Approved 22/03/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 2030806000; info@mhra.gov.uk), ref: CTA 52490/0004/001-0001 |
| 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 | 10/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 51 |
| 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 | 13/04/2023 |
| Date of final enrolment | 03/07/2023 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Belfast
BT9 6AD
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 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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/04/2024: Trial's existence confirmed by London-London Bridge Research Ethics Committee
