NCT05803850

A Study to Evaluate the Safety, Tolerability, PK and PD of HNC1058

A Randomized, Double-blind, Placebo-controlled, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC1058

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Guangzhou Henovcom Bioscience Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of HNC1058 given to healthy subjects, compared to placebo.

Conditions

• IPF

Interventions

Type	Name	Description
DRUG	HNC1058 Capsules	HNC1058 Capsules/Placebos, single dose, PO, starting dose of 10 mg escalating up to 80 mg；HNC1058 Capsules/Placebos, 50 mg, single dose, FED.

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-02-27
• Completion: 2024-03-08
• First posted: 2023-04-07
• Last updated: 2024-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study