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A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects

Inflammatory Disease Clinical Trial

Official title:
A Phase 1, Double-blind, Single and Multiple-Dose Study of Safety, Tolerability and Pharmacokinetics of Amilo-5MER in Healthy Volunteers

Clinical Trial Summary

This is a three-part, single Centre, double-blind, randomized, placebo-controlled first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3)

Clinical Trial Description

This is a three-part, single Centre, double-blind, randomized, placebo-controlled first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3). The study aim is to assess and characterize the safety and tolerability of single and multiple doses of amilo-5MER in healthy young adult subjects and single doses in healthy elderly subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05857215
Study type Interventional
Source Galmed Pharmaceuticals Ltd
Contact
Status Completed
Phase Phase 1
Start date March 5, 2021
Completion date July 1, 2021
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