The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects

NCT04422496 | Completed Phase 1 DMC

• 1 other identifier: HEC96719-P-03
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects

Conditions

Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Adverse event

  To assess the safety and tolerability of therapy.

  Baseline to day 21

Secondary Outcomes (7)

• Cmax

  predose to 96 hour after dosing

• AUC

  predose to 96 hour after dosing

• T½

  predose to 96 hour after dosing

• Tmax

  predose to 96 hour after dosing

• C4

  predose to 48 hour after dosing

Study Arms (2)

HEC96719 tablets

EXPERIMENTAL

part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B: There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg

Drug: HEC96719

placebo tablets

PLACEBO COMPARATOR

part A: There will be a total of 6 dose cohorts: 0.2 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg part B:There will be a total of 3 dose cohorts: 0.5 mg, 1 mg, 2 mg

Drug: HEC96719

Interventions

HEC96719 DRUG

single-Dose Study: Each dose of HEC96719 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study.

HEC96719 tablets; placebo tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
• Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
• Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception
• Able to comprehend and willing to provide a written Informed Consent Form (ICF) and to abide by the study restrictions.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• History of gallstone disease or diseases affecting the bile ducts.
• History of inflammation, ulceration, bleeding affecting the gastrointestinal tract.
• Alanine transaminase (ALT) or Glutamic oxalacetic transaminase(AST) is out of the normal range.
• Bilirubin is more than 1.5 x upper limit of normal.
• Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, and/or human immunodeficiency virus antibodies .
• History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-tuberculosis(TB) testing performed at screening.
• Positive QuantiFERON®-tuberculosis(TB) indicating possible tuberculosis infection.
• Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the course of the study.
• History of clinically significant opportunistic infection e.g. invasive candidiasis or pneumocystis pneumonia.
• Serious local infection e.g. cellulitis, abscess, or systemic infection e.g. septicemia, within 3 months prior to screening.
• Presence of fever (body temperature \>37.6 °C) e.g. a fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing.
• Subjects who are scheduled to receive an organ transplant or have received an organ transplant;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Melbourne VIC 3004, Australia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Jon Rankin, Doctor

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 9, 2020
• Study Start: August 10, 2020
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

AU (1)