Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and… (NCT06905847) | Clinical Trial Compass
CompletedPhase 1
Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Primary Efficacy of HSK39004 Suspension for Inhalation
China63 participantsStarted 2024-09-02
Plain-language summary
To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy of HSK39004 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease（COPD）.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
✓. 18 years to 45 years (inclusive), male and female;
✓. Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-26 kg/m2 (inclusive) ;
✓. Ability to perform acceptable and reproducible spirometry;
✓. Normal lung function during the screening period, no airway obstruction, FEV1 and forced vital capacity(FVC) are at least 80% of the predicted values;
✓. Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.
✓. Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
✓. Age ≥ 40 years , male and female;
Exclusion criteria
✕. Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
✕. Have a history of any malignant tumors;
✕. Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance (only for healthy subjects);
What they're measuring
1
adverse events
Timeframe: From the enrollment of the subjects to 72 hours after the last administration
✕. Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
✕. Acute respiratory infections occurred within 6 weeks before screening and/or before randomization;
✕. Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration;
✕. Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study (only for healthy subjects);
✕. Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening;