Evaluating the safety of Hemay005 tablets for COPD

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

This study tests the safety of Hemay005 tablets for people with COPD by comparing how different ways of taking the medication affect side effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 468 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Wuhu, Anhui)
• Trial ID: NCT06908642 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety of Hemay005 tablets in patients with Chronic Obstructive Pulmonary Disease (COPD) by comparing different administration methods, specifically titration versus non-titration. The study aims to assess the incidence of adverse reactions associated with the medication. Participants will receive either the Hemay005 tablet or a placebo, and their responses will be monitored throughout the trial. The trial is designed for individuals aged 18 to 65 who meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are males and females aged 18 to 65 with a BMI between 18.5 and 30.0.

Not a fit: Patients with significant clinical abnormalities or those who have participated in other trials within the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer treatment option for patients with COPD.

How similar studies have performed: While this approach is focused on safety evaluation, similar studies have shown promise in assessing new treatments for COPD.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Where this trial is running

Wuhu, Anhui

• The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Yuanwei Jia

Conditions Chronic Obstructive Pulmonary Disease