Phase 1 Trial: Quotient Code QSC303303, Sponsor Code LMNL6511C1002

ISRCTN ISRCTN96603462
DOI https://doi.org/10.1186/ISRCTN96603462
IRAS number 1011852
Secondary identifying numbers Quotient Code QSC303303, Sponsor Code LMNL6511C1002
Submission date
22/04/2025
Registration date
02/05/2025
Last edited
16/05/2025
Recruitment status
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. Full details will be added to the study record within 30 months after the trial has ended.

Contact information

Dr Clinical Trial Information
Public, Scientific

Liminal BioSciences Limited, 3rd Floor, 1 Ashley Road
Altrincham
WA14 2DT
United Kingdom

Email info@liminalbiosciences.com
Dr Nand Singh
Principal Investigator

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

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

Study information

Study designTwo part single centre randomized double-blind study to assess biomarkers safety tolerability and pharmacokinetics
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Pharmaceutical testing facility
Study typeOther
Participant information sheet Not available in web format
Scientific titlePhase 1 Trial: Quotient Code QSC303303, Sponsor Code LMNL6511C1002
Study objectivesThe sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Ethics approval(s)

Approved 14/05/2025, London - Surrey Borders Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 (0)20 7104 8057; surreyborders.rec@hra.nhs.uk), ref: 25/LO/0200

Health condition(s) or problem(s) studiedThe sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
InterventionThe sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Intervention typeDrug
Pharmaceutical study type(s)Pharmacokinetic, Pharmacodynamic
PhasePhase 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. Full details will be added to the study record within 30 months after the trial has ended.
Primary outcome measureThe sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Secondary outcome measuresThe sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Overall study start date01/04/2025
Completion date04/05/2026

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants66 (maximum of 72)
Key inclusion criteriaThe sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Key exclusion criteriaThe sponsor has confirmed that the trial meets the criteria for deferral of publication of the full details of the trial. Full details will be added to the study record within 30 months after the trial has ended.
Date of first enrolment02/06/2025
Date of final enrolment04/05/2026

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

Liminal BioSciences Limited
Industry

3rd Floor, 1 Ashley Road
Altrincham
WA14 2DT
England
United Kingdom

Email info@liminalbiosciences.com
Website https://liminalbiosciences.com/

Funders

Funder type

Industry

Liminal BioSciences Limited

No information available

Results and Publications

Intention to publish date04/11/2028
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planFull trial details will be published up to 30 months after the end of the trial. Publication of some of the 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 may be posted on or after the date of publication of trial details.
IPD sharing planThe 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

16/05/2025: The ethics approval was added.
02/05/2025: Trial's existence confirmed by MHRA.