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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: placebo; Drug: HEC53856

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single ascending; Drug or placebo, oral, fast, single dose ascending	Drug: placebo; oral administration; Other Names: HEC53856 matching placebo capsule; Drug: HEC53856; oral administration; Other Names: HEC53856 capsule
Experimental: multiple ascending; Drug or placebo, oral, fast, multiple dose ascending	Drug: placebo; oral administration; Other Names: HEC53856 matching placebo capsule; Drug: HEC53856; oral administration; Other Names: HEC53856 capsule
Experimental: Food Effect; Drug or placebo, oral, fed or fast, single dose	Drug: placebo; oral administration; Other Names: HEC53856 matching placebo capsule; Drug: HEC53856; oral administration; Other Names: HEC53856 capsule

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vz/F	Apparent volume of distribution	Up to 96 hours after dosing

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HEC53856-P-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No