Phase I trial: PXL 272092
| ISRCTN | ISRCTN45338135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45338135 |
| IRAS number | 1005630 |
| Secondary identifying numbers | IRAS 1005630, PXL 272092 |
- Submission date
- 19/05/2022
- Registration date
- 20/05/2022
- Last edited
- 20/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English Summary
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
Principal Investigator
Parexel Early Phase Clinical Unit
Level 7, Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 (0)808 134 6555 |
|---|---|
| drugtrial@parexel.com |
Scientific
Parexel Early Phase Clinical Unit
Level 7, Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 (0)808 134 6555 |
|---|---|
| drugtrial@parexel.com |
Public
Parexel Early Phase Clinical Unit
Level 7, Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 (0)808 134 6555 |
|---|---|
| drugtrial@parexel.com |
Study information
| Study design | Pharmacokinetic pharmacodynamic safety and tolerability study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Phase I trial: PXL 272092 |
| Study hypothesis | 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 05/05/2022, London-Brent REC (80 London Road, Skipton House, London, SE1 6LH, UK; +44(0)20 7104 8137; brent.rec@hra.nhs.uk), ref: 22/LO/0315 2. Approved 05/05/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0) 20 3080 6000; info@mhra.gov.uk), ref: CTA 46323/0005/001-0001 |
| Condition | 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) | |
| 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 | 19/04/2022 |
| Overall study end date | 30/09/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 8 |
| Participant inclusion criteria | Healthy human volunteer |
| Participant 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. |
| Recruitment start date | 29/06/2022 |
| Recruitment end date | 30/09/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
Sponsor information
Industry
P.O. Box 785
Lund
SE-220 07
Sweden
| Phone | +46 (0) 46 16 56 70 |
|---|---|
| info@hansabiopharma.com | |
| Website | http://www.hansabiopharma.com/ |
"ROR" |
https://ror.org/001r0mk78 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| 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 will 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 will 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
20/05/2022: Trial's existence confirmed by MHRA.
