NCT04481594

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Hepanova Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Non-Alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	HPN-01	25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 capsules
DRUG	Placebo	25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 placebo capsules

Timeline

• Start date: 2020-09-08
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2020-07-22
• Last updated: 2021-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study