Phase 1 trial: MAC Clinical Research: MAC180
| ISRCTN | ISRCTN16253842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16253842 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1008854 |
| Protocol serial number | IRAS 1008854; OMS906-NHV-004 |
| Sponsor | Omeros Corporation (United States) |
| Funder | Omeros Corporation |
- 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
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
Public, Scientific
201 Elliott Avenue West
Seattle
98119
United States of America
| Phone | +1 206-676-5000 |
|---|---|
| ctinfo@omeros.com |
Principal investigator
Citylabs 1.0, Nelson Street
Manchester
M13 9NQ
United Kingdom
| Phone | +44 0161 274 1603 |
|---|---|
| hamzahmalik@macplc.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase 1 single dose study |
| Secondary study design | Non randomised study |
| Scientific title | Phase 1 trial: MAC Clinical Research: MAC180 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 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) 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 | Not Specified |
| 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 | 30/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Not Specified |
| 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 | 29/02/2024 |
| Date of final enrolment | 30/10/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Kaman Court
1 Faraday Way
Blackpool
FY2 0JH
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 nontherapeutic clinical trials. |
Editorial Notes
22/02/2024: Trial's existence confirmed by Wales Research Ethics Committee 1.
