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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD 10mg | Experimental | A single oral dose of 10 mg |
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| SAD 20mg | Experimental | A single oral dose of 20 mg. Food effect will also be assessed at the same dose level. |
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| SAD 40mg | Experimental | A single oral dose of 40mg |
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| SAD 80 mg | Experimental | A single oral dose of 80 mg |
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| SAD 120 mg | Experimental | A single oral dose of 120 mg |
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| SAD 150 mg | Experimental | A single oral dose of 150 mg |
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| MAD 10mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPG1860 | Drug | 6 subjects randomized to active compound and 2 subjects randomized to placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day1-21 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | SAD: Day 1. MAD: Day 1 and Day14 |
| Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC InC | Baltimore | Maryland | 21201 | United States |
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Part 1 SAD: 6 cohorts Part 2 MAD: 3 cohorts
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| Experimental |
Dose regimen is once daily 10 mg for 14 consecutive days. |
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| MAD 30mg | Experimental | Dose regimen is once daily 30 mg for 14 consecutive days. |
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| MAD 90 mg | Experimental | Dose regimen is once daily 90mg for 14 consecutive days. |
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Maximum observed serum concentration
| SAD: up to 48 hours ; MAD: up to 14 days. |
| Tmax | Time to reach Cmax | 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 | SAD: up to 48 hours ; MAD: up to 14 days. |
| AUCinf | Area under the curve from the time of dosing extrapolated to infinity | SAD: up to 48 hours ; MAD: up to 14 days. |
| CL | Apparent total body clearance of the drug from plasma | SAD: up to 48 hours; MAD: up to 14 days |
| Vd | Apparent volume of distribution | 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 | 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 | 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 | 24 hours |