Phase
Condition
Healthy Volunteers
Treatment
HSK39004
Placebo
Clinical Study ID
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntarily sign the informed consent form, understand the trialprocedures, and bewilling 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) ;
Normal lung function during the screening period, no airway obstruction, FEV1 andforced vital capacity(FVC) are at least 80% of the predicted values;
Never smoked or have quit smoking for ≥ 12 months and have a previous smokinghistory of < 5 pack per years;
Subjects are willing to voluntarily use effectivecontraceptives from screening to atleast 3 months after the last dose administration.
Exclusion
Exclusion Criteria:
Have a history of severe and uncontrolled diseases, such ascardiovascular,respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systemsdiseases 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;
Previous or current gastrointestinal, liver, kidney, or other disease known tointerfere with drug absorption, distribution, metabolism, or excretion;
Acute respiratory infections occurred within 6 weeks before screening and/or beforerandomization;
Have a history of high consumption of grapefruit juice, methylxanthinerich food orbeverage within 48 hours before the administration;
Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) withinthe 3 months prior to screening;
Have a history of drug abuse prior to screening, or positive urine drug screen atscreening;
Blood donation (or blood loss) ≥400 mL within 3 months prior to the screening;
Subjects who have a allergic to any component of HSK39004 or allergic history;
Subjects who use any live vaccine within 30 days prior to screening;
Have participated in any clinical investigator within 3 months prior to screening;
A pregnant/lactating woman, or has a positive pregnancy test at screening or duringthe trial;
Not suitable for this study as judged by the investigator.
Study Design
Connect with a study center
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
ChinaSite Not Available

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