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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04422496




Registration number
NCT04422496
Ethics application status
Date submitted
1/06/2020
Date registered
9/06/2020
Date last updated
7/05/2021

Titles & IDs
Public title
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects
Scientific title
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC96719 Tablets in Healthy Subjects
Secondary ID [1] 0 0
HEC96719-P-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Fatty Liver Disease 0 0
Non-alcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HEC96719

Experimental: HEC96719 tablets - 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

Placebo comparator: placebo tablets - 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


Treatment: Drugs: HEC96719
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse event
Timepoint [1] 0 0
Baseline to day 21
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
predose to 96 hour after dosing
Secondary outcome [2] 0 0
AUC
Timepoint [2] 0 0
predose to 96 hour after dosing
Secondary outcome [3] 0 0
T½
Timepoint [3] 0 0
predose to 96 hour after dosing
Secondary outcome [4] 0 0
Tmax
Timepoint [4] 0 0
predose to 96 hour after dosing
Secondary outcome [5] 0 0
C4
Timepoint [5] 0 0
predose to 48 hour after dosing
Secondary outcome [6] 0 0
FGF19
Timepoint [6] 0 0
predose to 48 hour after dosing
Secondary outcome [7] 0 0
CL/F
Timepoint [7] 0 0
predose to 96 hour after dosing

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/02/2021
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
Melbourne VIC 300
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sunshine Lake Pharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT04422496
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon Rankin, Doctor
Address 0 0
Study Principal Investigator
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04422496