About this trial
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are:
1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects. 2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects.
Approximately 86 subjects will be enrolled in the study.
Eligibility criteria
Qualifiers
Willing to comply with protocol required visit schedule and visit requirements and provide written ICF;
Healthy adult male and female subjects, aged 18 to 45 years of age (inclusive) at the time of signing the ICF;
Body mass index between 18.0 and 32.0 kg/m2, inclusive;
Considered medically healthy as determined by the investigator, based on medical history and clinical evaluations including physical examination, clinical laboratory tests, vital sign measurements, and 12-Lead ECG;
Disqualifiers
Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the VG290131; history of other significant allergies or anaphylaxis, as determined by the investigator;
Considered by the investigator to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations;
Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention;
History of stomach or intestinal surgery or resection diseases including but not limited to, gastric band/gastric resection and/or intestinal resection and/or duodenal disease (i.e. celiac disease) which may potentially alter absorption and/or excretion of VG290131 (except for an appendectomy);
Trial design
Treatments tested in this trial
- VG290131
Treatment groups
10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Zhejiang Vimgreen Pharmaceuticals, Ltd.
Lead sponsor
Tigermed Consulting Co., Ltd
Collaborator