Phase I trial: Parexel Code: PXL277433

ISRCTN	ISRCTN24909354
DOI	https://doi.org/10.1186/ISRCTN24909354
IRAS number	1007366
Secondary identifying numbers	IRAS 1007366, Parexel PXL27743

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

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 David Steel
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
Email	david.steel@parexel.com

Study information

Study design	First-in-man safety, pharmacokinetics and pharmacodynamics trial in 88 healthy volunteers
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Safety
Participant information sheet	Not available in web format
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
Pharmaceutical study type(s)	Pharmacokinetic, Pharmacodynamic, Safety
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	15/05/2023
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	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Parexel International; Parexel Early Phase Clinical Unit

Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Sanofi-Aventis Recherche & Développement
Industry

1 avenue Pierre Brossolette
Chilly-Mazarin
91380
France

Email	uk-medicalinformation@sanofi.com
Website	https://www.sanofi.co.uk/en/contact

Funders

Funder type

Industry

Sanofi-Aventis Recherche & Développement

No information available

Results and Publications

Intention to publish date	02/03/2027
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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	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

Editorial Notes

16/11/2023: Study's existence confirmed by the MHRA.