NCT07314242

A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD

A Randomized, Double-blind, Single-dummy, Positive Drug and Placebo-controlled, Parallel Group, Multicenter, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Randomized, Double-blind, Single-dummy, positive drug and placebo-controlled, Parallel Group, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed description

This is a phase 2a, multicenter, randomized, double-blind, single-dummy, positive drug and placebo-controlled, parallel group study to evaluate the safety and efficacy of Hemay005 in adults with moderate to severe chronic obstructive pulmonary disease (COPD). Subjects will receive Hemay005 twice daily, or placebo, or positive drug roflumilast with a maximum treatment duration of 12 weeks. The study also includes an off-treatment safety follow-up period of 4 weeks.

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Type	Name	Description
DRUG	Hemay005 tablets	Subjects take Hemay005 tablets for 12 weeks.
DRUG	Roflumilast Oral Tablet	Subjects take roflumilast tablet for 12 weeks.
DRUG	Placebo tablet	Subjects take placebo tablet for 12 weeks.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

2 sites across 1 country: China