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

• Status: Completed
• Trial end date: 2021-02-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

Inclusion Criteria:

1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.

2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.

3. 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).

4. Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception

5. Able to comprehend and willing to provide a written Informed Consent Form (ICF) and to abide by the study restrictions.

Exclusion Criteria:

1. 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).

2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).

3. 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).

4. History of gallstone disease or diseases affecting the bile ducts.

5. History of inflammation, ulceration, bleeding affecting the gastrointestinal tract.

6. Alanine transaminase (ALT) or Glutamic oxalacetic transaminase(AST) is out of the normal range.

7. Bilirubin is more than 1.5 x upper limit of normal.

8. Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, and/or human immunodeficiency virus antibodies .

9. History of active tuberculosis or exposure to endemic areas within 8 weeks prior to QuantiFERON®-tuberculosis(TB) testing performed at screening.

10. Positive QuantiFERON®-tuberculosis(TB) indicating possible tuberculosis infection.

11. Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the course of the study.

12. History of clinically significant opportunistic infection e.g. invasive candidiasis or pneumocystis pneumonia.

13. Serious local infection e.g. cellulitis, abscess, or systemic infection e.g. septicemia, within 3 months prior to screening.

14. 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.

15. Subjects who are scheduled to receive an organ transplant or have received an organ transplant;

16. 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.

17. 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).

18. Use or intend to use any prescription medications/products, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).

19. 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).

20. 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.

21. 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.

22. Positive urine drugs of abuse screen at Screening or Check-in.

23. Smokers of more than 5 cigarettes per week or positive cotinine test at Screening or Check-in.

24. 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.

25. Receipt of blood products within 2 months prior to Check-in.

26. Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

27. Poor peripheral venous access.

28. Have previously completed or withdrawn from this study, and have previously received the investigational product.

29. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.