Phase I trial: Parexel Code: PXL277433
| ISRCTN | ISRCTN24909354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24909354 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1007366 |
| Protocol serial number | IRAS 1007366, Parexel PXL27743 |
| Sponsor | Sanofi-Aventis Recherche & Développement |
| Funder | Sanofi-Aventis Recherche & Développement |
- Submission date
- 15/11/2023
- Registration date
- 16/11/2023
- Last edited
- 16/11/2023
- 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
Public, Scientific, Principal investigator
Parexel Early Phase Clinical Unit (LONDON)
Northwick Park Hospital
Level 7
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 (0)7548098654 |
|---|---|
| david.steel@parexel.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | First-in-man safety, pharmacokinetics and pharmacodynamics trial in 88 healthy volunteers |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial: Parexel Code: PXL277433 [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 02/08/2023, Brent Research Ethics Committee Health Research Authority (2 Redman Place Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8128, +44 (0)207 104 8131; brent.rec@hra.nhs.uk), ref: 23/LO/0321; The HRA has approved deferral of publication of trial details. 2. Approved 17/08/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 29969/0159/001-0001; The HRA has approved deferral of publication of trial details |
| 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 30 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 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 | 30/08/2024 |
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 | 88 |
| Key inclusion criteria | Healthy human volunteers |
| 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 | 22/08/2023 |
| Date of final enrolment | 30/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Watford Road
Harrow
HA1 3UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
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
16/11/2023: Study's existence confirmed by the MHRA.
