NCT03886688

HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers

A Phase 1, Double-blind, Randomized, Placebo-controlled, Dose-escalation, Pharmacokinetic Study of Single and Multiple Oral Dosing of HEC53856, A Novel HIF-PHD Inhibitor, in Healthy Non-elderly Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.

Detailed description

This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HEC53856	oral administration
DRUG	placebo	oral administration

Timeline

• Start date: 2019-05-14
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2019-03-22
• Last updated: 2023-04-13

Locations

1 site across 1 country: China