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

Sponsor
Ganzhou Hemay Pharmaceutical Co., Ltd
Study ID
NCT07314242
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hemay005 tablets — DRUG
    Subjects take Hemay005 tablets for 12 weeks.
  • Roflumilast Oral Tablet — DRUG
    Subjects take roflumilast tablet for 12 weeks.
  • Placebo tablet — DRUG
    Subjects take placebo tablet for 12 weeks.

Study Details

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).

Key Dates

Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hemay005 group
    Hemay005 tablets
  • Placebo Comparator: Placebo group
    Placebo tablets
  • Active Comparator: Roflumilast group
    Roflumilast tablets

Primary Outcome Measure

Sputum biomarkers [ Time Frame: Change from baseline to week 4 ]

Central Contacts

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