ISRCTN ISRCTN16253842
DOI https://doi.org/10.1186/ISRCTN16253842
IRAS number 1008854
Secondary identifying numbers IRAS 1008854; OMS906-NHV-004
Submission date
22/02/2024
Registration date
23/02/2024
Last edited
23/02/2024
Recruitment status
No longer recruiting
Overall study status
Deferred
Condition category
Not Specified
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 Omeros Clinical Trial Information
Public, Scientific

201 Elliott Avenue West
Seattle
98119
United States of America

Phone +1 206-676-5000
Email ctinfo@omeros.com
Dr Hamzah Malik
Principal Investigator

Citylabs 1.0, Nelson Street
Manchester
M13 9NQ
United Kingdom

Phone +44 0161 274 1603
Email hamzahmalik@macplc.com

Study information

Study designPhase 1 single dose study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeOther
Scientific titlePhase 1 trial: MAC Clinical Research: MAC180 The full scientific title will be published within 30 months after the end of the trial.
Study objectivesThe 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 11/01/2024, Wales Research Ethics Committee 1 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2920 785738; Wales.REC1@wales.nhs.uk), ref: 23/WA/0330

2. Approved 12/01/2024, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0) 20 3080 6000;; info@mhra.gov.uk), ref: 49709/0006/001-0001

Health condition(s) or problem(s) studiedThe 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.
InterventionThe 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 typeNot Specified
Primary outcome measureThe 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.
Secondary outcome measuresThe 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.
Overall study start date29/11/2023
Completion date30/10/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupNot Specified
SexBoth
Target number of participants16
Key inclusion criteriaThe 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 criteriaThe 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 enrolment29/02/2024
Date of final enrolment30/10/2024

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MAC Clinical Research Blackpool
Clinical Research Centre
Kaman Court
1 Faraday Way
Blackpool
FY2 0JH
United Kingdom

Sponsor information

Omeros Corporation (United States)
Industry

201 Elliott Avenue West
Seattle
98119
United States of America

Phone +1 206-676-5000
Email ctinfo@omeros.com
Website http://www.omeros.com/
ROR logo "ROR" https://ror.org/01r5k6556

Funders

Funder type

Industry

Omeros Corporation
Government organisation / For-profit companies (industry)
Alternative name(s)
Omeros, Omeros Corp, OMS
Location
United States of America

Results and Publications

Intention to publish date30/04/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planNot provided at time of registration
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 nontherapeutic clinical trials.

Editorial Notes

22/02/2024: Trial's existence confirmed by Wales Research Ethics Committee 1.