Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
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
The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 in Healthy Male and Female Subjects
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.
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