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The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single dose HEC585(pilot trial arm) | Experimental | Healthy subjects receive a single dose of HEC585 |
|
| Single and Mulltiple doses HEC585( Part 1, Cohort 1) | Experimental | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
|
| Single and Mulltiple doses HEC585( Part 1, Cohort 2) | Experimental | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
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| Single and Mulltiple doses HEC585( Part 1, Cohort 3) | Experimental | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
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| Single dose of HEC585 (Part 2,Fed/Fasting) | Experimental | Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC585 | Drug | single or Mulltiple doses up to 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses | To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD | up to 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters - AUC0-∞ | area under the concentration versus time curve (AUC) from time zero to infinity | up to 96 hours |
| PK parameters - Cmax | Geometric Mean of Maximum Observed Plasma Concentration of HEC585 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Ascending Single and Multiple Dose Study is Double-blind design; Food Effect Study is open-label design.
| two-period study at 400 mg dose group (part 3,Fed) | Experimental | Healthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles. |
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| placebo | Drug | single or Mulltiple doses up to 10 days |
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| up to 96 hours |
| PK parameters -tmax | maximum observed plasma concentration | up to 96 hours |
| PK parameters -t½ | apparent terminal elimination half-life | up to 96 hours |
| PK parameters -Vz/F | apparent volume of distribution | up to 96 hours |
| PK parameters - MRT | the Mean Residence Time | up to 96 hours |
| PK parameters -CL/F | the Apparent Clearance | up to 96 hours |
| PK parameters -R | the Accumulation Ratio | up to 96 hours |
| Food Effect | Effect of Food on PK parameters of HEC585 | up to 96 hours |