Phase I trial, Quotient code: QSC205601

ISRCTN	ISRCTN10521680
DOI	https://doi.org/10.1186/ISRCTN10521680
EudraCT/CTIS number	2021-000600-38
IRAS number	304054
Secondary identifying numbers	IRAS 304054; Quotient code: QSC205601

Submission date: 31/01/2022
Registration date: 01/02/2022
Last edited: 01/02/2022

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 when the results are published, which will be within 30 months after the trial has ended.

Contact information

Dr Stuart Mair
Public

Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone	+44 (0)3303031000
Email	recruitment@weneedyou.co.uk

Dr Stuart Mair
Scientific

Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone	+44 (0)3303031000
Email	recruitment@weneedyou.co.uk

Dr Stuart Mair
Principal Investigator

Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone	+44 (0)1159749000
Email	recruitment@weneedyou.co.uk

Study information

Study design	Phase I trial to assess safety, tolerability and pharmacokinetics in 116 healthy volunteers
Primary study design	Other
Secondary study design
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format
Scientific title	Phase I trial, Quotient code: QSC205601 [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 when the results are published, which will be within 30 months after the trial has ended.
Ethics approval(s)	1. Approved 24/11/2021, London Bridge Research Ethics Committee (London HRA Centre, 2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 1048202, +44 (0)207 1048124; londonbridge.rec@hra.nhs.uk), REC ref: 21/LO/0761 2. Approved 31/12/2021, MHRA (10 South Colonnade, Canary Wharf, London E14 4PU, UK; +44 (0)20 3080 6000; info@nhra.gov.uk), ref: CTA 04935/0192/001-0001 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 when the results are published, which will be 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 when the results are published, which will be 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 when the results are published, which will be 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 when the results are published, which will be 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 when the results are published, which will be within 30 months after the trial has ended.
Overall study start date	13/10/2021
Completion date	06/10/2022

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	116
Key inclusion criteria	Healthy human volunteer
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 when the results are published, which will be within 30 months after the trial has ended.
Date of first enrolment	02/02/2022
Date of final enrolment	06/10/2022

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Quotient Sciences

Trent House
Mere Way
Ruddington Fields Business Park
Nottingham
NG11 6JS
United Kingdom

Sponsor information

Novartis (Switzerland)
Industry

Lichtstr. 35
Basel
4056
Switzerland

Email	novartis.email@novartis.com
Website	https://www.novartis.com/
"ROR"	https://ror.org/02f9zrr09

Funders

Funder type

Industry

Novartis Pharma AG

No information available

Results and Publications

Intention to publish date	06/04/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Trial information and summary results 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 1 information.
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			26/07/2023	No	No

Editorial Notes

01/02/2022: Trial's existence confirmed by London Bridge Research Ethics Committee.