Phase I Trial: Quotient Code QSC205832

ISRCTN	ISRCTN16482972
DOI	https://doi.org/10.1186/ISRCTN16482972
EudraCT/CTIS number	2022-02525-10
IRAS number	1006182
Secondary identifying numbers	IRAS 1006182, Quotient Code: QSC205832

Submission date: 22/03/2023
Registration date: 23/03/2023
Last edited: 23/03/2023

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

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 Litza McKenzie
Principal Investigator

Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone	+44 (0)330 3031000
Email	recruitment@weneedyou.co.uk

Ms Cecile Hauschka
Public

Lichtstrasse 35
Basel
4056
Switzerland

Phone	+41 (0)79 704 14 71
Email	cecile.hauschka@novartis.com

Ms Cecile Hauschka
Public

Lichtstrasse 35
Basel
4056
Switzerland

Phone	+41 (0)79 704 14 71
Email	cecile.hauschka@novartis.com

Study information

Study design	Phase I trial to assess safety and pharmacokinetics in 16 healthy volunteers
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format
Scientific title	Phase I Trial: QSC205832 [The full scientific title will be published within 30 months after the end of the trial]
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 03/03/2023, HSC REC A (Office for Research Ethics Committees in Northern Ireland (ORECNI), Business Services Organisation, Lissue Industrial Estate West, Rathdown Walk, Moira Road, Lisburn, Co. Antrim BT28 2RF, UK; +44 (0)28 95 361400; reca@hscni.net), ref: 22/NI/0169 2. Approved 03/03/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 04935/0231/001-0001
Condition	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)
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	15/11/2022
Overall study end date	19/11/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	16
Participant 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.
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	28/03/2023
Recruitment end date	19/11/2023

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Quotient Sciences

Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Sponsor information

Novartis (Switzerland)
Industry

Lichtstrasse 35
Basel
4056
Switzerland

Phone	+41 (0)79 704 14 71
Email	cecile.hauschka@novartis.com
Website	https://www.novartis.com/
"ROR"	https://ror.org/02f9zrr09

Funders

Funder type

Industry

Novartis Pharma
Private sector organisation / For-profit companies (industry)

Alternative name(s): Novartis Deutschland GmbH, Novartis Pharma GmbH, Novartis Deutschland
Location: Germany

Results and Publications

Intention to publish date	30/01/2026
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 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

23/03/2023: Trial's existence confirmed by the MHRA.