The Safety, Tolerability and Pharmacokinetic Study of Litapiprant Tablets in Healthy Male and Female Subjects

Study Overview
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Brief Summary
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The Safety, Tolerability and Pharmacokinetic Study of Asthma Treatment Drug Litapiprant Tablets in Healthy Male and Female subjects.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Litapiprant Tablets in Healthy Subjects

Conditions
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Asthma

Intervention / Treatment
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* Drug: Litapiprant Tablet


Participation Criteria
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Eligibility Criteria
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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) <90mmHg or >140mmHg, and/or sitting diastolic blood pressure (DBP) <60mmHg or >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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 25mg single doses<br>Intervention Drug: 25mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily | Drug: Litapiprant Tablet<br>* Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells<br>|
| Placebo Comparator: 50mg single doses<br>Intervention Drug: 50mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily | Drug: Litapiprant Tablet<br>* Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells<br>|
| Placebo Comparator: 100mg single doses<br>Intervention Drug: 100mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily | Drug: Litapiprant Tablet<br>* Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells<br>|
| Placebo Comparator: 200mg single doses<br>Intervention Drug: 200mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily | Drug: Litapiprant Tablet<br>* Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells<br>|
| Placebo Comparator: 400mg single doses<br>Intervention Drug: 400mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily | Drug: Litapiprant Tablet<br>* Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells<br>|
| Placebo Comparator: 600mg single doses<br>Intervention Drug: 600mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily | Drug: Litapiprant Tablet<br>* Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells<br>|
| Placebo Comparator: 800mg single doses<br>Intervention Drug: 800mg Litapiprant Tablet administered orally once daily Intervention Drug: Matching Placebo Tablet administered orally once daily | Drug: Litapiprant Tablet<br>* Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To assess the safety and tolerability after a single dose of Litapiprant Tablets | Baseline to day 8 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ | area under the concentration versus time curve (AUC) from time zero to infinity | Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing | 
| AUC0-t | AUC from time zero to the time of the last quantifiable concentration time zero to the time of the last quantifiable concentration | Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing | 
| Cmax | maximum observed plasma concentration | Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing | 
| tmax | time of the maximum observed plasma concentration | Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing | 
| t½ | apparent terminal elimination half-life | Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing | 
| Vz/F | apparent volume of distribution | Prior to dosing（0 hour）and 0.25 hour、0.5 hour、1 hour、1.5 hours、2 hours、3 hours、4 hours、6 hours、8 hours、10 hours、12 hours、24 hours、36 hours、48 hours、72 hours、96 hours after dosing |