NCT03092102

The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects

A Phase I, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 in Healthy Male and Female Subjects

Detailed description

This will be a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts. Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Up to 48 subjects will be studied in up to 6 groups (Groups A1 to A6), with each group consisting of 8 subjects. Each subject will participate in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours postdose), except for Group A3, which will participate in a second treatment period for a food effect evaluation. Each subject in Group A3 will participate in 2 treatment periods separated by a minimum of 7 days. Dosing of subjects in the fed state in Group A3 can commence after review of the safety data from Group A4. Part B will comprise a multiple-dose, sequential-group study. Up to 36 subjects will be studied in up to 3 groups (Groups B1 to B3), with each group consisting of 12 subjects. Part B of the study may start after completion of Group A5, at a dose equal or less than given in Groups A1 to A3.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	HEC585	HEC585, a pyrimidone compound, is structurally related to pirfenidone, a pyridine compound.

Timeline

• Start date: 2017-05-20
• Primary completion: 2019-02-25
• Completion: 2019-02-25
• First posted: 2017-03-27
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study