This is a randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults.
Aged 18 to 45 years old, males or females;
Males weight no less than 50 kg, females weight no less than 45 kg, with body mass index of 19 to 26 kg/m²;
Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT and B-ultrasound of liver, gallbladder, pancreas, spleen, kidney and thyroid results are normal or considered abnormal without clinical significance by the investigator;
Volunteers who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
Volunteers with hypersensitivity to preparation or any of the excipients;
Volunteers with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
Volunteers with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;Volunteers with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);
Volunteers with a history of diseases affecting bone marrow hematopoietic function or reducing immunological function (including leukemia, myelodysplastic syndrome, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis, etc.) or treatment history (tumor chemotherapy or radiotherapy, use of immunosuppressants, etc.);
Parallel
VV261 5mg group
Drug2 subjects will receive VV261 5mg, orally
VV261 20mg Group
Drug6 subjects receive VV261 20mg,orally; 2 subjects will receive placebo,orally.
VV261 50mg group
Drug6 subjects receive VV261 50mg,orally; 2 subjects will receive placebo,orally.
VV261 100mg group
Drug6 subjects receive VV261 100mg,orally; 2 subjects will receive placebo,orally.
VV261 150mg group
Drug6 subjects receive VV261 150mg,orally; 2 subjects will receive placebo,orally.
VV261 300mg group
Drug6 subjects receive VV261 300mg,orally; 2 subjects will receive placebo,orally.
VV261 500mg group
Drug6 subjects receive VV261 500mg,orally; 2 subjects will receive placebo,orally.
VV261 750mg group
Drug6 subjects receive VV261 750mg,orally; 2 subjects will receive placebo,orally.
VV261 1000mg group
Drug6 subjects receive VV261 1000mg,orally; 2 subjects will receive placebo,orally.
Cmax
maximum observed plasma concentration
AUC0-t
area under the plasma concentration time curve from time zero to the last measurable concentration
AUC0-∞
area under the plasma concentration-time curve from time zero to infinity
Tmax
time at which Cmax occurs
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