Study of WPV01 in Healthy Subjects

Phase I Study on the Safety, Tolerability, Pharmacokinetics, and Food Effect Evaluation of WPV01 and WPV01 Co-administrated Ritonavir in Healthy Subjects

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WPV01 and WPV01 Co-administrated With Ritonavir in Healthy Adult Subjects.

Inclusion Criteria:

• Subjects signed an informed consent form with full understanding of the test content, procedure and possible adverse effects
• Chinese healthy male or female subjects between aged from 18 to 45 years
• Subjects must agree to comply with the contraceptive requirements during the trial and for 3 months after the last dose
• Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index in the range of 18.0 ~ 28.0 kg/m2 (including 18.0 and 28.0)
• Subjects must be willing to understand and comply with study procedures and limitations, have the ability to complete the trial as planned, and be able to communicate effectively with the investigator

Exclusion Criteria:

• Participants who have special dietary requirements and cannot abide by the provided food
• Pregnant or lactating women; Women who have pregnancy plan 1 month before trail, during trail or within 3 months after last dose; Women with positive serum pregnancy tests at screening or baseline
• Participants who have evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease
• Participants who have history of any other acute or chronic illness
• Participants who have known allergy to any ingredient in the study treatment drug
• Participants who are judged by the investigator to be unsuitable to participate in this study