A Food-Effect Study of BPI-16350 in Healthy Subjects

A Phase 1, Single-center, Open-Label, Randomized, 2 Period Crossover Study to Estimate the Effect of Food on the Pharmacokinetics of BPI-16350 in Chinese Healthy Volunteers After a Single Oral Administration

This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.

Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).

Inclusion Criteria:

• Healthy subjects aged 18~45 (including 18 and 45 years old);
• Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 ~ 26kg /m2;
• Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
• The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
• Able to comprehend and willing to sign an informed consent form.

Exclusion Criteria:

• History of significant hypersensitivity to any drug compound or food；
• Significant history or clinical manifestation of any significant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, musculoskeletal,hematological disorder；
• Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody is positive；
• Family history of long QTc syndrome; History or presence of an abnormal ECG；
• Drug abusers, smokers or alcoholics；
• Use of any medications within 14 days prior to the first administration；
• Donation of blood ≥ 200 mL or receipt of blood products within 3 months before enrollment, or plan on blood donation during the study period；
• Participation in any other investigational drug study or receive any vaccine within 3 months before enrollment；
• Female subjects who are pregnant or lactating；the serum HCG test of women with fertility is postive at Screening.