NCT04422496

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC96719 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects

Detailed description

This study consists of a single-dose study and a multiple-dose study, both using a single-center, randomized, double-blind, placebo-controlled, dose-escalation design： I. Single-Dose Study There will be a total of 6 dose cohorts. Each cohort will include 10 subjects, of which 8 receives HEC96719 tablets and 2 receives placebo, regardless of gender. Each subject will only participate in one dose cohort. Each cohort will be divided into 2 group. The first group consists of 2 sentinels, one receiving active and one placebo. The second group will consist of the remainder of the cohort (7 active and 1 placebo) and, following review of the available safety data, will be dosed 48 hours after the sentinel group. Subjects can leave the pharmacy after their biological samples are collected on day 3. The last safety follow-up visit is to be performed on day 7±1 via telephone. Subjects in each cohort will receive a single dose of HEC96719 or placebo in the fasted state on day 1, and safety evaluation is to be performed on day 3 and 7. II. Multi-Dose Study There will be a total of 3 dose cohorts. Each cohort will consist of 12 subjects, of which 10 receive HEC96719 tablets and 2 receive placebo, the dose regimen will comprise no less than once a day and will not exceed 4 times daily dosing for 7 consecutive days (study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study). Each subject will only participate in one dose cohort. Subjects will reside at the pharmacy from the day before dosing (D-1) to 96 h after the last dose. Subjects can leave pharmacy after their biological samples are collected. The last safety follow-up visit is to be performed 168±24 h after the last dose via telephone.

Conditions

• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	HEC96719	single-Dose Study: Each dose of HEC96719 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study.

Timeline

• Start date: 2020-08-10
• Primary completion: 2021-02-23
• Completion: 2021-02-23
• First posted: 2020-06-09
• Last updated: 2021-05-07

Locations

1 site across 1 country: Australia