COPD (Chronic Obstructive Pulmonary Disease)Phase 2NCT07314242
A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD
A Phase 2 study testing Hemay005 tablets and Roflumilast Oral Tablet in people with COPD (Chronic Obstructive Pulmonary Disease), run by Ganzhou Hemay Pharmaceutical Co., Ltd at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Hemay005 tablets and Roflumilast Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 40 years old at the time of signing the informed consent form, both gender;
- Subjects with an established diagnosis of COPD (according to GOLD 2025) at least 12 months before the screening visit, with chronic bronchitis (defined as productive cough for at least 3 months in each of the prior two consecutive years) and/or with chronic productive cough at least 12 months prior to screening;
- Confirmed diagnosis of chronic obstructive pulmonary disease at the screening visit, FEV1 (forced expiratory volume in 1 second)/FVC (forced vital capacity) ratio<70% after albuterol use, and FEV1 after albuterol use>30% predicted of normal value and equal or smalled than 70% predicted value at the screening visit;
- Subjects on regular maintenance therapy: inhaled glucocorticoids (ICS), LAMA, or LABA, or any combination thereof. Received maintenance therapy for at least 6 months prior to screening; Maintenance therapy must not change the dosage of these drugs from 28 days before signing the informed consent form until the end of the trial (16 weeks or safety visit after early withdrawal).
- At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided).
- Subjects voluntarily participate in this clinical trial and sign the informed consent form.
Who cannot join
- Subjects with a prior history of asthma or concurrent diagnosis of asthma, with or without active disease, are excluded.
- Subjects with a moderate or severe COPD exacerbation i.e. resulting in the use of systemic corticosteroids (oral/IV/IM corticosteroids) and/or antibiotics or need for hospitalisation or a lower respiratory tract infection 6 weeks prior to screening.
- Diseases that in the opinion of the investigator may interfere with clinical assessments, such as bronchiectasis, sarcoidosis, cystic fibrosis, pulmonary hypertension, interstitial lung disease, bronchiolitis, pneumonectomy, lung cancer, congestive heart failure, diffuse bronchiolitis, silicosis, etc.
- COPD with emphysema phenotype according to the investigator's judgment and/or medical history records (emphysema phenotype is defined as alveolar destruction leading to permanent airway obstruction, in addition to cough and sputum, subjects usually have severe symptoms of dyspnea, shortness of breath, etc.); or have alpha1-antitrypsin deficiency.
- Patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) should be assessed for all patients during screening: patients with positive hepatitis B surface antigen (HBsAg) will be excluded; patients with HBsAg (negative), HBsAb (negative or positive) and HBcAb (positive) should be tested for HBV-DNA, and if the HBV-DNA result is positive, patient will be excluded; if the HBV-DNA result is negative, patients can be enrolled in the study.), chronic hepatitis C virus (HCV) infection (patients with positive hepatitis C virus antibody (HCVAb) excluded) or human immunodeficiency virus (HIV) infection (patients with positive human immunodeficiency virus (HIV) antibody excluded) or Syphilis (TP) infection (excluded patients with Treponema pallidum antibody (Anti-TP) positive).
- . The investigator judged that the patient had other conditions that were not suitable for entry into this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Tianjin Fourth Central Hospital
Tianjin, 300074
Liyu Li, M.D.
China People's Armed Police Force Characteristic Medical Center
Tianjin, 300162
Bin Liu, M.D., 86-137-5257-5109, iamicehe@163.com
About this study
Official title: 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
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).
Read the 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.
- Being tested
- Hemay005 tablets, Roflumilast Oral Tablet, Placebo tablet
- Keywords
- COPD, biomarkers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005 tabletsDrug
Subjects take Hemay005 tablets for 12 weeks.
Roflumilast Oral TabletDrug
Subjects take roflumilast tablet for 12 weeks.
Placebo tabletDrug
Subjects take placebo tablet for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hemay005 group | Experimental | Hemay005 tablets Receives: Drug: Hemay005 tablets |
| Placebo group | Placebo comparator | Placebo tablets Receives: Drug: Placebo tablet |
| Roflumilast group | Active comparator | Roflumilast tablets Receives: Drug: Roflumilast Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum biomarkers
Alpha-2 macroglobulin, Interleukin 1b, Leukotriene B4, Myeloperoxidase, Neutrophil elastase, Interleukin 6, Interleukin 8, etc.
Measured: Change from baseline to week 4
Sputum cell count
Total cell count Absolute and percent of neutrophils, eosinophils, macrophages and lymphocytes differential cell count.
Measured: Change from baseline to week 4
Blood Biomarkers
Interleukin 1b, Interleukin 33, CXC motif chemokine ligand 1, Interleukin 8, Myeloperoxidase, Interleukin 6, Monocyte chemotactic protein 1, Macrophage inflammatory protein 1b, Matrix Metalloproteinase 9, etc
Measured: Change from baseline to week 4
Secondary outcomes (3)
Sputum biomarkers
Alpha-2 macroglobulin, Interleukin 1b, Leukotriene B4, Myeloperoxidase, Neutrophil elastase, Interleukin 6, Interleukin 8, etc
Measured: Change from baseline to week 12
Sputum cell count
Total cell count Absolute and percent of neutrophils, eosinophils, macrophages and lymphocytes differential cell count.
Measured: Change from baseline to week 12
Blood Biomarkers
Interleukin 1b, Interleukin 33, CXC motif chemokine ligand 1, Interleukin 8, Myeloperoxidase, Interleukin 6, Monocyte chemotactic protein 1, Macrophage inflammatory protein 1b, Matrix Metalloproteinase 9, etc
Measured: Change from baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Single-dummy, positive drug and placebo-controlled, Parallel Group design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314242
- Sponsor's protocol ID
- HM005COPD2S01
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07314242
- Acronym / sponsor ID
- HM005COPD2S01
- Keywords
- COPD, biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-blind, Single-dummy, positive drug and placebo-controlled, Parallel Group design
| Arm | Type | Receives |
|---|---|---|
| Hemay005 group | Experimental | Drug: Hemay005 tabletsHemay005 tablets |
| Placebo group | Placebo comparator | Drug: Placebo tabletPlacebo tablets |
| Roflumilast group | Active comparator | Drug: Roflumilast Oral TabletRoflumilast tablets |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age at least 40 years old at the time of signing the informed consent form, both gender;
- Subjects with an established diagnosis of COPD (according to GOLD 2025) at least 12 months before the screening visit, with chronic bronchitis (defined as productive cough for at least 3 months in each of the prior two consecutive years) and/or with chronic productive cough at least 12 months prior to screening;
- Confirmed diagnosis of chronic obstructive pulmonary disease at the screening visit, FEV1 (forced expiratory volume in 1 second)/FVC (forced vital capacity) ratio<70% after albuterol use, and FEV1 after albuterol use>30% predicted of normal value and equal or smalled than 70% predicted value at the screening visit;
- Subjects on regular maintenance therapy: inhaled glucocorticoids (ICS), LAMA, or LABA, or any combination thereof. Received maintenance therapy for at least 6 months prior to screening; Maintenance therapy must not change the dosage of these drugs from 28 days before signing the informed consent form until the end of the trial (16 weeks or safety visit after early withdrawal).
- At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided).
Key exclusion criteria (6 listed)
- Subjects with a prior history of asthma or concurrent diagnosis of asthma, with or without active disease, are excluded.
- Subjects with a moderate or severe COPD exacerbation i.e. resulting in the use of systemic corticosteroids (oral/IV/IM corticosteroids) and/or antibiotics or need for hospitalisation or a lower respiratory tract infection 6 weeks prior to screening.
- Diseases that in the opinion of the investigator may interfere with clinical assessments, such as bronchiectasis, sarcoidosis, cystic fibrosis, pulmonary hypertension, interstitial lung disease, bronchiolitis, pneumonectomy, lung cancer, congestive heart failure, diffuse bronchiolitis, silicosis, etc.
- COPD with emphysema phenotype according to the investigator's judgment and/or medical history records (emphysema phenotype is defined as alveolar destruction leading to permanent airway obstruction, in addition to cough and sputum, subjects usually have severe symptoms of dyspnea, shortness of breath, etc.); or have alpha1-antitrypsin deficiency.
- Patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) should be assessed for all patients during screening: patients with positive hepatitis B surface antigen (HBsAg) will be excluded; patients with HBsAg (negative), HBsAb (negative or positive) and HBcAb (positive) should be tested for HBV-DNA, and if the HBV-DNA result is positive, patient will be excluded; if the HBV-DNA result is negative, patients can be enrolled in the study.), chronic hepatitis C virus (HCV) infection (patients with positive hepatitis C virus antibody (HCVAb) excluded) or human immunodeficiency virus (HIV) infection (patients with positive human immunodeficiency virus (HIV) antibody excluded) or Syphilis (TP) infection (excluded patients with Treponema pallidum antibody (Anti-TP) positive).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemay005 tabletsSubjects take Hemay005 tablets for 12 weeks. | Drug | Hemay005 group |
| Roflumilast Oral TabletSubjects take roflumilast tablet for 12 weeks. | Drug | Roflumilast group |
| Placebo tabletSubjects take placebo tablet for 12 weeks. | Drug | Placebo group |
Primary outcome
Sputum biomarkers
Time frame: Change from baseline to week 4
Alpha-2 macroglobulin, Interleukin 1b, Leukotriene B4, Myeloperoxidase, Neutrophil elastase, Interleukin 6, Interleukin 8, etc.
Sputum cell count
Time frame: Change from baseline to week 4
Total cell count Absolute and percent of neutrophils, eosinophils, macrophages and lymphocytes differential cell count.
Blood Biomarkers
Time frame: Change from baseline to week 4
Interleukin 1b, Interleukin 33, CXC motif chemokine ligand 1, Interleukin 8, Myeloperoxidase, Interleukin 6, Monocyte chemotactic protein 1, Macrophage inflammatory protein 1b, Matrix Metalloproteinase 9, etc
3 secondary outcomes
Sputum biomarkers
Time frame: Change from baseline to week 12
Sputum cell count
Time frame: Change from baseline to week 12
Blood Biomarkers
Time frame: Change from baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemay005 tablets and Roflumilast Oral Tablet in people with COPD (Chronic Obstructive Pulmonary Disease), run by Ganzhou Hemay Pharmaceutical Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zimeng Wang (86-22-24929667, wangzimeng@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sputum biomarkers (time frame: Change from baseline to week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.