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

NCT07314242 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-02

No results posted yet for this study

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).

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

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.

Sponsors & Collaborators

  • Ganzhou Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07314242 on ClinicalTrials.gov