NCT04512170

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects

A Randomized, Double-Blind, Placebo-Controlled Study of Ascending Single and Multiple Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Randomized, Open-label，Crossover, Food Effect Study of HEC585 in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	HEC585	single or Mulltiple doses up to 10 days
DRUG	placebo	single or Mulltiple doses up to 10 days

Timeline

• Start date: 2020-07-13
• Primary completion: 2021-08-23
• Completion: 2021-08-23
• First posted: 2020-08-13
• Last updated: 2022-03-15

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study