HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers

Study Overview
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Brief Summary
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To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.

Detailed Description
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This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.

Official Title
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A Phase 1, Double-blind, Randomized, Placebo-controlled, Dose-escalation, Pharmacokinetic Study of Single and Multiple Oral Dosing of HEC53856, A Novel HIF-PHD Inhibitor, in Healthy Non-elderly Volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: HEC53856
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteers age: 18-45 years old(18 and 45 included). B.W. male> 50kg, female> 45kg, BMI - 18-28 kg/m^2 females must not be pregnant and males and females must agree to use contraception during the study. able to give informed consent and comply with protocol. physical examination and vital signs without clinically significant abnormalities. agree to use contraceptive methods after informed consent acquisition through 6 months after the last administration of the study drug. Exclusion Criteria: history or presence of severe gastrointestinal or systemic disorders (e.g. respiratory, endocrine, immunological, dermatological, neurological, psychiatric, renal, hepatic disease etc.) history or presence of significant alcoholism or drug abuse within past 5 years smokers, who smoke more than 5 cigarettes per day within past 3 months heavy drinker, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine); donated blood or massive blood loss within 3 months before screening (>450 mL） have any disease that increases the risk of bleeding or thrombus, such as acute gastritis or stomach and duodenal ulcers; clinically significant laboratory findings during screening history or presence of clinically significant ECG abnormalities participated in drug research study within past 3 months used over-the-counter/ prescription/ herbal medications/ supplements within past 14 days. Strenuous activity (as assessed by the investigator) is prohibited from 2 weeks prior to admission until discharge from the unit. female in pregnancy or lactation. viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis. the investigator believes that the one should not be included

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single ascending<br>Drug or placebo, oral, fast, single dose ascending | Drug: HEC53856<br>* oral administration<br>* Other names: HEC53856 capsule;Drug: placebo<br>* oral administration<br>* Other names: HEC53856 matching placebo capsule;|
| Experimental: multiple ascending<br>Drug or placebo, oral, fast, multiple dose ascending | Drug: HEC53856<br>* oral administration<br>* Other names: HEC53856 capsule;Drug: placebo<br>* oral administration<br>* Other names: HEC53856 matching placebo capsule;|
| Experimental: Food Effect<br>Drug or placebo, oral, fed or fast, single dose | Drug: HEC53856<br>* oral administration<br>* Other names: HEC53856 capsule;Drug: placebo<br>* oral administration<br>* Other names: HEC53856 matching placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events [Safety and Tolerability] | To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule | Up to Day 10 after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration | Up to 96 hours after dosing | 
| Cmax | Maximum observed plasma concentration | Up to 96 hours after dosing | 
| Tmax | Time of the maximum observed plasma concentration | Up to 96 hours after dosing | 
| T T½ | Apparent terminal elimination half-life | Up to 96 hours after dosing |