Phase I trial, Quotient Code: QSC300414

ISRCTN	ISRCTN85847953
DOI	https://doi.org/10.1186/ISRCTN85847953
IRAS number	1007622
Secondary identifying numbers	IRAS 1007622, Quotient Code: QSC300414

Submission date: 05/05/2023
Registration date: 09/05/2023
Last edited: 09/05/2023

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 sponsor has confirmed that the trial meets the criteria for 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 Nand Singh
Principal Investigator

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

Phone	+44 (0)330 303 1000
Email	Recruitment@weneedyou.co.uk

Dr Fabrizio Giordanetto
Scientific

120 West 45th Street
39th Floor
New York
NY 10036
United States of America

Phone	+1 (0) 212 849 0880
Email	Fabrizio.Giordanetto@DEShawResearch.com

Dr Fabrizio Giordanetto
Public

120 West 45th Street
39th Floor
New York
NY 10036
United States of America

Phone	+1 (0) 212 849 0880
Email	Fabrizio.Giordanetto@DEShawResearch.com

Study information

Study design	Two-part single-center double-blind randomiZed study to assess PK, safety and tolerability in 104 healthy volunteers
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Pharmaceutical testing facility
Study type	Other
Participant information sheet	Not available in web format
Scientific title	Phase I trial, Quotient Code: QSC300414 [The full scientific title will be published within 30 months after the end of the trial]
Study objectives	The sponsor has confirmed that the trial meets the criteria for 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. Submitted 18/04/2023, HSC REC B (ORECNI, Business Services Organisation, Lissue Industrial Estate West, Lisburn, Co. Antrim BT28 2RF, Northern Ireland, UK; +44 (0)28 9536 1400; recb@hscni.net), ref: 23/NI/0043 2. Submitted 18/04/2023, MHRA (10 South Colonnade, Canary Wharf, London E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 57954/0001/001-0001
Health condition(s) or problem(s) studied	The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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	18/04/2023
Completion date	24/03/2024

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	104
Key inclusion criteria	The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. The full details will be added tot he study record within 30 months after the trial has ended.
Date of first enrolment	27/06/2023
Date of final enrolment	14/03/2024

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Quotient Sciences Limited

Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Sponsor information

D. E. Shaw Research
Industry

120 West 45th Street
39th Floor
New York
NY 10036
United States of America

Phone	+1 (0) 212 849 0880
Email	fabrizio.giordanetto@deshawresearch.com
Website	https://www.deshawresearch.com/
"ROR"	https://ror.org/02s04h872

Funders

Funder type

Industry

D. E. Shaw Research

No information available

Results and Publications

Intention to publish date	24/09/2026
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

09/05/2023: Trial's existence confirmed by the MHRA.