NCT03294707

Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10

A Phase 1 Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of AG10 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Eidos Therapeutics, a BridgeBio company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects

Detailed description

Up to 48 healthy volunteers will be given a single dose of AG10 or placebo and be monitored for safety and tolerability over a 5-day period. Up to 48 healthy volunteers will be given multiple doses of AG10 or placebo and be monitored for safety and tolerability over a 15-day period.

Conditions

• Amyloid Cardiomyopathy, Transthyretin-Related

Interventions

Type	Name	Description
DRUG	AG10 oral tablet	Active single ascending dose
DRUG	Placebo Oral Tablet	Placebo single dose

Timeline

• Start date: 2017-09-11
• Primary completion: 2018-02-05
• Completion: 2018-05-18
• First posted: 2017-09-27
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study