Phase I Trial: Quotient Code QSC205832

ISRCTN	ISRCTN16482972
DOI	https://doi.org/10.1186/ISRCTN16482972
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	2022-02525-10
Integrated Research Application System (IRAS)	1006182
Protocol serial number	IRAS 1006182, Quotient Code: QSC205832
Sponsor	Novartis (Switzerland)
Funder	Novartis Pharma

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 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 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

Primary study design	Interventional
Study design	Phase I trial to assess safety and pharmacokinetics in 16 healthy volunteers
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Phase I Trial: QSC205832 [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 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
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	19/11/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	16
Key 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.
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	28/03/2023
Date of final enrolment	19/11/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Quotient Sciences

Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.

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

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