This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HPG1860 orally administered in healthy subjects.
In SAD and MAD studies, all subjects are randomized in a 3:1 ratio. In SAD study , there are 6 cohorts (8 subjects/cohort) with dose levels of 10mg, 20 mg, 40 mg, 80 mg, 120 mg and 150 mg respectively. Blood samples will be collected for safety, PK and PD assessments. After the completion of Cohort 2 (20 mg) in SAD study, following a 7-day washout period, the same 8 subjects will receive another single oral dose of 20 mg HPG1860 after a standard high fat/high calorie breakfast (the fed condition). PK blood samplings will be collected and Cmax and AUC will be used for assessing the food effect. In MAD study, there are 3 cohorts (8 subjects/cohort) with dose levels of 10mg, 30mg and 90 mg, respectively and dosing regimen is once daily for 14 consecutive days. Blood samples will be collected for safety, PK and PD assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
6 subjects randomized to active compound and 2 subjects randomized to placebo
Pharmaron CPC InC
Baltimore, Maryland, United States
After single ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts
To investigate the safety and tolerability of orally administered SAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.
Time frame: Day1-8
After multiple ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts
To investigate the safety and tolerability of orally administered MAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.
Time frame: Day1-21
Effect of HPG1860 on Blood Concentration of FGF19 and 7-alpha-hydroxy-4-cholesten-3-one (C4)
To assess blood FGF19 and C4 changes vs placebo after orally administered SAD and MAD of HPG1860
Time frame: SAD: Day 1. MAD: Day 1 and Day14
Cmax
Maximum observed serum concentration
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
Tmax
Time to reach Cmax
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
AUClast
Area under the curve from the time of dosing to the time of the last measurable concentration
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
AUCinf
Area under the curve from the time of dosing extrapolated to infinity
Time frame: SAD: up to 48 hours ; MAD: up to 14 days.
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CL
Apparent total body clearance of the drug from plasma
Time frame: SAD: up to 48 hours; MAD: up to 14 days
Vd
Apparent volume of distribution
Time frame: SAD: up to 48 hours; MAD: up to 14 days
Effect of Food on Cmax of HPG1860
To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating Cmax
Time frame: up to 48 hours
Effect of Food on AUCinf of HPG1860
To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUCinf
Time frame: up to 48 hours
Effect of Food on AUC0-24h of HPG1860
To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUC0-24h
Time frame: 24 hours