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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03092102
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 20, 2017
Completion date February 25, 2019

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