the safety, tolerability and pharmacokinetic study of litapiprant tablets in healthy male and female subjects

Conditions: Asthma

Summary: the safety, tolerability and pharmacokinetic study of asthma treatment drug litapiprant tablets in healthy male and female subjects.

this was a randomized，double-blind, placebo-controlled, single ascending dose, single-center study to assess the safety, tolerability and pharmacokinetic of litapiprant tablets in healthy male and female subjects. a total of 60 healthy subjects were divided into 7 groups. group 1 consist of 4 subjects, 3 subjects will receive litapiprant tablets and 1 subject will receive placebo.group 2,3,5,6 consist of 8 subjects respectively, in each group, 6 subjects will receive litapiprant tablets and 2 subjects will receive placebo.group 4,7 consist of 12 subjects respectively, in each group, 10 subjects will receive litapiprant tablets and 2 subjects will receive placebo.

Eligibility criteria:
inclusion criteria: * male or female, overall healthy subjects，female vs male 1:1 ratio; * between 18 and 45 years of age, inclusive, similar ages; * body weight should be≥50 kg; body mass index (bmi) is between 19.0 and 28.0 kg/m2, inclusive; * able to comprehend and sign the icf voluntarily prior to initiate the study; * able to communicate well with the investigator and complete the study according to the protocol. exclusion criteria: * pregnant or nursing female, or plan for pregnancy within 6 months; * a clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ecg), or clinical laboratory results at screening; * has a positive test for hepatitis b surface antigen, hepatitis c antibody, syphilis antibody， or hiv antibody . a clinically significant abnormal finding on hbv-dna test ; * sitting systolic blood pressure (sbp) \ 140mmhg, and/or sitting diastolic blood pressure (dbp) \ 90mmhg at screening; * with the history of using any drug which will inhibit or induce liver metabolize drug and/or will infect gastric acid within 1 month before randomization; * receipt of any medication including over the counter preparations and vitamins within 14 days of the first study day; * history of cardiovascular, immune system, severe digestive system, circulatory system, respiratory system, urinary system , nervous system,tumor diseases; * suffering from blood diseases such as coagulopathy; * patients with a history of mental illness or active mental illness; * have undergone major surgery within 6 months before enrollment; * a history of gastrointestinal, liver ,kidney diseases likely to influence drug absorption within 6 months before enrollment; * drug or alcohol abuse; * history of drug abuse and drug use within 1 year prior to the study; * habitual consumption of grapefruit juice, tea, coffee and/or caffeinated beverages, which cannot be withdrawn during the trial; * the average daily smoking volume is \>5 within 3 months prior to the study; * a history of hypersensitivity and/or idiosyncrasy to any of the test compounds or related drugs or excipients employed in this study; * participation in a clinical study within 3 months of the first dose of study drug; * donation of blood within 3 months of the first dose of study drug or have a plan to donate blood; * cannot be tolerant to oral drugs; * poor peripheral venous access conditions; * the investigator believes that it should not be included; * additional exclusion criteria apply.