Chronic Obstructive Pulmonary DiseasePhase 1NCT06908642
Evaluation the Safety of hemay005 Tablets
A Phase 1 study testing Hemay005 tablet in people with Chronic Obstructive Pulmonary Disease, run by Anhui Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Hemay005 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 3 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Male and female subjects aged 18 to 65 years old (inclusive of 18 and 65);
- 2) Weight: Male should be no less than 50.0 kg, female no less than 45.0 kg. Body Mass Index (BMI) [ = weight (kg) / height2 (m2) ] should be within the range of 18.5 to 30.0 kg/m2 (inclusive of boundary values);
- 3) Before the trial, they have been thoroughly informed about the nature, significance, possible benefits, as well as possible inconveniences and potential risks of the trial, and have voluntarily participated in this clinical trial. They can communicate well with the researchers, comply with all requirements of the entire study, and have signed a written informed consent form.
Who cannot join
- 1) Participants who have participated in other drug/medical device trials within the previous 3 months (based on the use of the trial drugs/medical devices);
- 2) Those with clinical manifestations of abnormalities that need to be excluded, including but not limited to diseases in the nervous system, cardiovascular system, hematological and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism and bone system;
- 3) Those with specific allergy histories (asthma, urticaria, eczema, etc.), or with allergic constitution (such as those allergic to two or more drugs, foods or pollen), or those known to be allergic to this product;
- 4) Participants who have lost or donated blood exceeding 400ml within the previous 3 months, or those who plan to donate blood during the trial;
- 5) Pregnant or lactating women, or those who have a fertility plan or donation plan for sperm or eggs within two weeks before the trial or within 3 months after the last administration, and are unwilling or have not taken effective contraceptive measures;
- 6) General physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, hepatitis B and C, AIDS, syphilis, and HIV tests, pregnancy test for females, etc.) within the previous 7 days before randomization; electrocardiogram results within the previous 14 days before randomization judged by clinical doctors as abnormal with clinical significance; chest X-ray results within the previous 3 months before randomization judged by clinical doctors as abnormal with clinical significance;
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- 7) Alcohol breath test results greater than 0.0mg/100ml or positive results in drug abuse screening;
- 8) Those who have a history of severe vomiting or diarrhea within the previous 7 days or any other diseases or physiological conditions that may interfere with the test results;
- 9) Those who have suffered from major clinical diseases or undergone major surgical operations within 3 months before screening;
- 10) Those who consume more than 14 units of alcohol per week (1 unit = 17.7 mL ethanol, which is equivalent to 357 mL of 5% alcohol beverage, 43 mL of 40% alcohol liquor, or 147 mL of 12% wine) within 3 months before screening, or those who cannot abstain from alcohol during the test;
- 11) Those who smoke more than 5 cigarettes per day on average within 3 months before screening, or those who cannot stop using any tobacco products during the test;
- 12) Those who consume excessive tea, coffee and/or beverages rich in caffeine (more than 8 cups, 1 cup = 250 mL) every day within 3 months before screening.
- 13) Exclude those who have used any drugs that inhibit or induce liver drug-metabolizing enzymes within the past 30 days (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids; inhibitors - SSRI class antidepressants, cimetidine, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines).
- 14) Those with a history of tuberculosis or those with active tuberculosis during the screening period;
- 15) Those who are unable to eat or have difficulty swallowing;
- 16) Those who have used any prescription drugs, over-the-counter drugs, health supplements, herbal products or vaccines within 14 days before randomization or have stopped taking them for less than 5 half-lives;
- 17) Those who have used Apremilast or Hemay005 tablets in the past;
- 18) Those who cannot tolerate venipuncture and/or have a history of fainting or needle shock;
- 19) Those who have used any drugs within one year before screening;
- 20) Those who, in the researcher's opinion, have poor compliance or any factors that make them unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000
About this study
Official title: Evaluation of the Safety of Hemay005 Tablets in Multiple Doses and Different Administration Methods in Multiple Administrations for Chinese Adult Healthy Subjects in a Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial
Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Hemay005 tablet, Placebo
- 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 tabletDrug
Hemay005 is a small molecule PDE4 inhibitor.
PlaceboDrug
Placebos are the same as drugs, but contain no Hemay005.
| Study group | Role | What they receive |
|---|---|---|
| 0-45mg Hemay005 | Active comparator | By using titration method, the dosage of the drug was gradually increased from 0 to 45 mg BID for 14 days Receives: Drug: Hemay005 tablet |
| 45mg Hemay005 | Active comparator | The subjects took the medicine twice a day, 45 mg each time, for 14 days. Receives: Drug: Hemay005 tablet |
| 0-60mg Hemay005 | Active comparator | By using titration method, the dosage of the drug was gradually increased from 0 to 60 mg BID for 14 days Receives: Drug: Hemay005 tablet |
| 60mg Hemay005 | Active comparator | The subjects took the medicine twice a day, 60 mg each time, for 14 days. Receives: Drug: Hemay005 tablet |
| 0-75 mg Hemay005 | Active comparator | By using titration method, the dosage of the drug was gradually increased from 0 to 75 mg BID for 14 days Receives: Drug: Hemay005 tablet |
| 75 mg Hemay005 | Active comparator | The subjects took the medicine twice a day, 75 mg each time, for 14 days. Receives: Drug: Hemay005 tablet |
| placebo | Placebo comparator | The subjects took the medicine twice a day. In the first week, they took placebos; in the second week, they took 60 mg hemay005 each time, for a total of 14 days of medication. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions.
Number of Participants With Treatment-Related Adverse Events as Assessed by Grade of Adverse Event
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start25 Dec 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908642
- Sponsor's protocol ID
- HM005CO1S01
- Status last verified
- Jun 2025
- First submitted
- 18 Mar 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Hemay005 Tablets in Multiple Doses and Different Administration Methods in Multiple Administrations for Chinese Adult Healthy Subjects in a Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT06908642
- Acronym / sponsor ID
- HM005CO1S01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- Anhui Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 3 Apr 2025 (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.
Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 0-45mg Hemay005 | Active comparator | Drug: Hemay005 tabletBy using titration method, the dosage of the drug was gradually increased from 0 to 45 mg BID for 14 days |
| 45mg Hemay005 | Active comparator | Drug: Hemay005 tabletThe subjects took the medicine twice a day, 45 mg each time, for 14 days. |
| 0-60mg Hemay005 | Active comparator | Drug: Hemay005 tabletBy using titration method, the dosage of the drug was gradually increased from 0 to 60 mg BID for 14 days |
| 60mg Hemay005 | Active comparator | Drug: Hemay005 tabletThe subjects took the medicine twice a day, 60 mg each time, for 14 days. |
| 0-75 mg Hemay005 | Active comparator | Drug: Hemay005 tabletBy using titration method, the dosage of the drug was gradually increased from 0 to 75 mg BID for 14 days |
| 75 mg Hemay005 | Active comparator | Drug: Hemay005 tabletThe subjects took the medicine twice a day, 75 mg each time, for 14 days. |
| placebo | Placebo comparator | Drug: PlaceboThe subjects took the medicine twice a day. In the first week, they took placebos; in the second week, they took 60 mg hemay005 each time, for a total of 14 days of medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Male and female subjects aged 18 to 65 years old (inclusive of 18 and 65);
- 2) Weight: Male should be no less than 50.0 kg, female no less than 45.0 kg. Body Mass Index (BMI) [ = weight (kg) / height2 (m2) ] should be within the range of 18.5 to 30.0 kg/m2 (inclusive of boundary values);
- 3) Before the trial, they have been thoroughly informed about the nature, significance, possible benefits, as well as possible inconveniences and potential risks of the trial, and have voluntarily participated in this clinical trial. They can communicate well with the researchers, comply with all requirements of the entire study, and have signed a written informed consent form.
Key exclusion criteria (20 listed)
- 1) Participants who have participated in other drug/medical device trials within the previous 3 months (based on the use of the trial drugs/medical devices);
- 2) Those with clinical manifestations of abnormalities that need to be excluded, including but not limited to diseases in the nervous system, cardiovascular system, hematological and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism and bone system;
- 3) Those with specific allergy histories (asthma, urticaria, eczema, etc.), or with allergic constitution (such as those allergic to two or more drugs, foods or pollen), or those known to be allergic to this product;
- 4) Participants who have lost or donated blood exceeding 400ml within the previous 3 months, or those who plan to donate blood during the trial;
- 5) Pregnant or lactating women, or those who have a fertility plan or donation plan for sperm or eggs within two weeks before the trial or within 3 months after the last administration, and are unwilling or have not taken effective contraceptive measures;
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 tabletHemay005 is a small molecule PDE4 inhibitor. | Drug | 0-45mg Hemay005, 0-60mg Hemay005, 0-75 mg Hemay005, 45mg Hemay005, 60mg Hemay005, 75 mg Hemay005 |
| PlaceboPlacebos are the same as drugs, but contain no Hemay005. | Drug | placebo |
Primary outcome
Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions.
Time frame: 14 Days
Number of Participants With Treatment-Related Adverse Events as Assessed by Grade of Adverse Event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hemay005 tablet in people with Chronic Obstructive Pulmonary Disease, run by Anhui Hemay Pharmaceutical Co., Ltd at 1 site 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 3 inclusion and 20 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the influence of different administration methods (titration/non-titration) of Hemay005 tablets on the incidence of adverse reactions. (time frame: 14 Days). 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 9 Dec 2025.