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Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects

Safety Clinical Trial

Official title:
AM1476 - A Phase I, Double-blind, Placebo-controlled, Single- and Multiple-oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects

Clinical Trial Summary

This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and PK of single and multiple ascending oral doses of AM1476 in healthy subjects.

Clinical Trial Description

Part A (SAD); In the SAD part of the study, single oral doses of AM1476 will be administered in up to 9 sequential groups, each consisting of 8 subjects randomised to recieve either AM1476 or placebo in a 3:1 ratio. The first 2 subjects in each group will be dosed in a sentinel fashion, 1 subject will receive AM1476 and the other will receive placebo as randomised. The SAD part incorporating a 2-period crossover arm for a food-effect evaluation in 2 groups. Part B (MAD); The MAD part of the study will explore multiple ascending dosing of AM1476 for 10 days. AM1476 will be administered in up to 6 sequential groups, each consisting of 8 subjects randomised to recieve either AM1476 or placebo in a 3:1 ratio. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04691115
Study type Interventional
Source AnaMar AB
Contact
Status Completed
Phase Phase 1
Start date December 16, 2020
Completion date January 26, 2022
View Details
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