Status:
COMPLETED
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects
Lead Sponsor:
Sunshine Lake Pharma Co., Ltd.
Conditions:
Non-alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
Detailed Description
This study consists of a single-dose study and a multiple-dose study, both using a single-center, randomized, double-blind, placebo-controlled, dose-escalation design： I. Single-Dose Study There will ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to Check-in.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- History of drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening, or hard drugs (such as cocaine, phencyclidine, and crack) within 1 year prior to screening.
- Alcohol consumption of \> 21 units per week for males and \> 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
- Positive urine drugs of abuse screen at Screening or Check-in.
- Smokers of more than 5 cigarettes per week or positive cotinine test at Screening or Check-in.
- Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges within 7 days prior to Check-in, consumption of caffeine-containing foods and beverages within 72 hours prior to Check-in, or consumption of alcohol within 48 hours prior to Check-in.
- Receipt of blood products within 2 months prior to Check-in.
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study, and have previously received the investigational product.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2021
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04422496
Start Date
August 10 2020
End Date
February 23 2021
Last Update
May 7 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nucleus Network Pty Ltd
Melbourne, Melbourne VIC 3004, Australia