NCT04691115

Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: AnaMar AB · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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 receive 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. 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 receive either AM1476 or placebo in a 3:1 ratio.

Conditions

• Safety
• Tolerability

Interventions

Type	Name	Description
DRUG	AM1476	AM1476 Capsules
DRUG	Placebo	Placebo Capsules

Timeline

• Start date: 2020-12-16
• Primary completion: 2021-12-08
• Completion: 2021-12-08
• First posted: 2020-12-31
• Last updated: 2024-08-02
• Results posted: 2024-08-02

Locations

1 site across 1 country: United Kingdom