SAD MAD Study of Amilo-5MER in Healthy Volunteers (QSC204810) [COVID-19]
Research type
Research Study
Full title
A Phase 1, Double-blind, Single and Multiple-Dose Study of Safety, Tolerability and Pharmacokinetics of Amilo-5MER in Healthy Volunteers
IRAS ID
294135
Contact name
Bella Shusterman
Contact email
Sponsor organisation
Galmed Research & Development Ltd
Eudract number
2021-000088-65
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
Summary of Research
The Sponsor is developing the test medicine, Amilo-5MER, for the potential treatment of inflammatory bowel diseases (IBD) and the inflammation of the lungs and other organs affected by coronavirus disease 2019 (COVID-19). IBD are long term conditions which occur when the body’s immune system attacks the gut.
The study will try to identify the safety and tolerability of single and multiple ascending doses of the test medicine. It will also try to investigate how the test medicine is taken up by the body (pharmacokinetics). The test medicine will be administered as a subcutaneous injection (ie under the skin).
The study will consist of three parts involving up to 56 healthy male volunteers and 8 healthy elderly male and female volunteers. Sentinel dosing will be used in Part 1 and 2, meaning two volunteers will be dosed 24 hours before the rest of the group, so that their safety data can be reviewed before the rest are dosed. One will receive active test medicine and the other will receive the placebo.
In Part 1, up to 40 volunteers will be enrolled in up to five cohorts and will receive a single dose of the test medicine or placebo. In Part 2, up to 16 volunteers be enrolled in up to two cohorts and will receive the test medicine or placebo once or twice daily, for five days. In Part 3, up to 8 elderly volunteers (aged 65-80) will receive a single dose of the test medicine or placebo.
In Parts 1 and 3 volunteers will remain in clinic for at least 48 hours post-dose (Day 3). In Part 2, volunteers will remain in clinic until at least Day 7 (48 hours post-final dose). For all Parts, a follow up visit will take place 7 to 10 days post-final dose for safety monitoring.
Summary of Results
Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0049
Date of REC Opinion
3 Mar 2021
REC opinion
Further Information Favourable Opinion