A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorZhejiang Vimgreen Pharmaceuticals, Ltd.
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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
VG290131
DrugThe study drug and matching placebo will be administered orally.
Treatment groups
86 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: SAD Cohort 1Experimental treatment 1 intervention
Group B: SAD Cohort 2 (FE Study)Experimental treatment 1 intervention
Group C: SAD Cohort 3Experimental treatment 1 intervention
Group D: SAD Cohort 4Experimental treatment 1 intervention
Group E: SAD Cohort 5Experimental treatment 1 intervention
Group F: SAD Cohort 6Experimental treatment 1 intervention
Group G: MAD Cohort 1Experimental treatment 1 intervention
Group H: MAD Cohort 2Experimental treatment 1 intervention
Group I: MAD Cohort 3Experimental treatment 1 intervention
Group J: MAD Cohort 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability of VG290131 by TEAEs
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the incidence, severity, and causality of treatment-emergent adverse events (TEAEs).
Time frame
From admission to discharge, up to 12 days.2
To evaluate the safety and tolerability of VG290131 by 12-Lead ECG
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in 12-Lead ECG (RR, PR, QRSD, QT, and QTc).
Time frame
From admission to discharge, up to 12 days.3
To evaluate the safety and tolerability of VG290131 by vital signs
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in vital signs (Blood pressure, heart rate, body temperature, and respiration rate).
Time frame
From admission to discharge, up to 12 days.4
To evaluate the safety and tolerability of VG290131 by physical examinations
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in physical examinations (Skin and mucosa, lymph nodes, head, eyes, ears, nose, and throat (HEENT), chest, abdomen, spine and limbs, musculoskeletal system, and nervous system).
Time frame
From admission to discharge, up to 12 days.Secondary outcomes
1
To evaluate PK parameter Cmax of VG290131 after a single dose
Cmax of VG290131 under fasted and fed conditions will be calculated after a single dose.
Time frame
From admission to discharge, up to 12 days.2
To evaluate PK parameter Tmax of VG290131 after a single dose
Tmax of VG290131 under fasted and fed conditions will be calculated after a single dose.
Time frame
From admission to discharge, up to 12 days.3
To evaluate PK parameter AUC0-t of VG290131 after a single dose
AUC0-t of VG290131 under fasted and fed conditions will be calculated after a single dose.
Time frame
From admission to discharge, up to 12 days.4
To evaluate PK parameter AUC0-inf of VG290131 after a single dose
AUC0-inf of VG290131 under fasted and fed conditions will be calculated after a single dose.
Time frame
From admission to discharge, up to 12 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang Vimgreen Pharmaceuticals, Ltd.
Lead sponsor
Tigermed Consulting Co., Ltd
Collaborator
Source ClinicalTrials.gov