Phase 1 Trial: CA38132
| ISRCTN | ISRCTN67246142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67246142 |
| IRAS number | 1006689 |
| Secondary identifying numbers | IRAS 1006689, CA38132 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Nadine Abdullah
Public, Scientific, Principal Investigator
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
| Study design | Phase 1 Safety Study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Safety |
| Participant information sheet | No participant information sheet available |
| 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 |
| Pharmaceutical study type(s) | Pharmacokinetic |
| 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 | 21/10/2022 |
| 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 | Both |
| Target number of participants | 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
- Northern Ireland
- United Kingdom
Study participating centre
Celerion GB Limited
22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom
Belfast
BT9 6AD
United Kingdom
Sponsor information
Pliant (United States)
Industry
Industry
331 Oyster Point Boulevard
South San Francisco
CA 94080
United States of America
| Phone | +1 650-481-6770 |
|---|---|
| gcosgrove@pliantrx.com | |
| Website | https://pliantrx.com/ |
"ROR" |
https://ror.org/02myr1w18 |
Funders
Funder type
Industry
Pliant Therapeutics Inc.
No information available
Results and Publications
| Intention to publish date | 10/02/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details may be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. Results may be posted on or after the date of publication of full trial details. |
| 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. |
Editorial Notes
15/04/2024: Trial's existence confirmed by London-London Bridge Research Ethics Committee
