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A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects

Non-Alcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo Controlled, Sequential Parallel Group, Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPN-01

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled first-in-human study in which the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered HPN-01 will be evaluated in healthy subjects

Clinical Trial Description

This study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when HPN-01 is orally administered as single doses and as multiple doses to healthy subjects. The study will be conducted in 2 parts: a single ascending dose (SAD) phase (Part 1) and a multiple ascending dose (MAD) phase (Part 2). One cohort of Part 1 will receive HPN-01 after a standard high fat/high calorie breakfast (the fed condition) to investigate the effect of food on the pharmacokinetics of HPN-01. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
  • Non-Alcoholic Steatohepatitis (NASH)
Clinical Trial Details
NCT number NCT04481594
Study type Interventional
Source Hepanova Inc.
Contact Michelle Pluviose, MS
Phone 201-416-7763
Email mpluviose@frontagelab.com
Status Recruiting
Phase Phase 1
Start date September 8, 2020
Completion date July 2021
View Details
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