ISRCTN ISRCTN14668776
DOI https://doi.org/10.1186/ISRCTN14668776
Integrated Research Application System (IRAS) 1013199
CRO Study Code QSC303694
Sponsor Neurocol Operations Sàrl
Funder Neurocol Operations Sàrl
Submission date
04/06/2026
Registration date
24/06/2026
Last edited
24/06/2026
Recruitment status
Not yet 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

This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.

Contact information

Dr David Everton
Principal investigator

Mere Way, Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom

Phone +44 (0)1159749000
Email recruitment@weneedyou.co.uk
Clinical Operations
Scientific, Public

Avenue de la Gare 39
Lausanne
1003
Switzerland

Phone +41 (0)21 711 3970
Email info@oculis.com

Study information

Primary study designInterventional
AllocationN/A: single arm study
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentSingle
PurposePhase I study in healthy volunteers
Scientific titleCTIMP - Quotient Sciences code: QSC303694 [The full scientific title will be added on or before the deferral expiry date]
Study objectives This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Ethics approval(s)

Approved 08/06/2026, London – Harrow Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048357; harrow.rec@hra.nhs.uk), ref: 26/LO/0330

Health condition(s) or problem(s) studiedHealthy volunteers
InterventionThis is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Intervention typeDrug
PhasePhase I
Drug / device / biological / vaccine name(s)This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Primary outcome measure(s)
  1. [Outcome name] measured using [Metric or method of measurement] at [Timepoint(s)]. This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Key secondary outcome measure(s)
Completion date12/08/2026

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit65 Years
SexMale
Target sample size at registration8
Key inclusion criteriaThis is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Key exclusion criteriaThis is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date.
Date of first enrolment06/07/2026
Date of final enrolment12/08/2026

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

04/06/2026: Study's existence confirmed by the MHRA.