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Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

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ClinicalTrials.gov Identifier: NCT04536532
Recruitment Status : Not yet recruiting
First Posted : September 2, 2020
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sunshine Lake Pharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 28, 2020
First Posted Date  ICMJE September 2, 2020
Last Update Posted Date September 2, 2020
Estimated Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
  • Adverse Events [ Time Frame: Time Frame: From Days 1-35 ]
    Incidence of adverse events
  • Cmax [ Time Frame: Time Frame: Day 1-7 ]
    Maximum plasma concentration of study drugs
  • AUC [ Time Frame: Time Frame: Day 1-7 ]
    Maximum plasma concentration of study drugs
  • HBV DNA [ Time Frame: Time Frame: Day 29-35 ]
    Hepatitis B virus DNA
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Official Title  ICMJE A Single-center, Randomized, Double-blind, Single and Multiple Dosing, Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Brief Summary The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug HEC121120 in Healthy subjects and in patients with chronic hepatitis B
Detailed Description

This study consists of two parts: healthy subjects and chronic hepatitis B patients. Healthy subjects will conduct a single-dose, multiple-dose and food effect study.

I. Single-Dose Study:There will be a total of 6 dose cohorts(25 mg, 50 mg, 100 mg, 400 mg, 600 mg, 800 mg). 25 mg cohort as experimental cohort, plans to enroll 4 subjects (male or female) who will use HEC121120 tablets . The other else cohorts will include 10 subjects, of which 8 receives HEC121120 tablets and 2 receives placebo, regardless of gender. Each subject will only participate in one dose cohort. Each cohort will be divided into 2 group. The first group consists of 3 sentinels, two receiving active and one placebo. The second group will consist of the remainder of the cohort (6 active and 1 placebo) and, following review of the available safety data, will be dosed 24 hours after the sentinel group. Subjects can leave the pharmacy after their biological samples are collected on day 5. Subjects in each cohort will receive a single dose of HEC121120 or placebo in the fasted state on day 1, and safety evaluation is to be performed on day 2 and 5.

II. Food effect: There will be 1 dose cohort (200 mg), only to be admitted to the 100 mg dose cohort if a single dose has been completed and is safe and well tolerated. A total of 18 subjects were enrolled in this dose cohort, divided into two groups A and B (9 subjects in each group, 8 subjects in each group received HEC121120 and 1 received the placebo, with the ratio of male to female as close as possible. All subjects were required to participate in a single dose and food influence study on pharmacokinetics. Two cycles of cross-dose administration were performed, with a washout period of 7 days. Four sentinels were first enrolled in group A, and their safety indexes were evaluated by the investigator at least 24 h after administration. If tolerated, the remaining 5 sentinels could be enrolled in group A, and the remaining 4 sentinels could be enrolled in group B. The safety indexes were evaluated by the investigator at least 24 h after administration, if tolerated, the remaining 5 sentinels could be enrolled in group B.

III. Multi-Dose Study: There will be 1 dose(200 mg) cohort which will consist of 12 subjects, of which 10 receive HEC121120 tablets and 2 receive placebo, with the ratio of male to female as close as possible. All subjects will receive HEC121120 or placebo for 5 consecutive days (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). Subjects can leave pharmacy after their biological samples are collected. Safety evaluation is to be performed on day 3 and 7.

IV:Chronic hepatitis B patients: There will be a total of 3 dose cohorts (100、200、400 mg). Each cohort will consist of 14 subjects, of which 12 receive HEC121120 tablets and placebo(Entecavir simulation tablet), 2 receive Entecavir and placebo(HEC121120 simulation tablet). It is necessary to determine the administration method and dose for patients with chronic hepatitis B based on the results of the tolerance and PK study of healthy subjects. Each subject will only participate in one dose cohort.Initially, the drug frequency was set as once a day for 28 consecutive days. Safety and antiviral activity evaluation is to be performed on day 7, 14, 21±2, 29, 35±2.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE
  • Drug: HEC121120 tablets

    single-Dose Study: Each dose of HEC121120 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/Patients with chronic hepatitis B: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/or multiple-dose study.

  • Drug: HEC121120 placebo tablets

    single-Dose Study: Each dose of HEC121120 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/Patients with chronic hepatitis B: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/or multiple-dose study.

  • Drug: entecavir tablets
    Patients with chronic hepatitis B:Administered Entecavir orally once daily for consecutive 28 days in fasted state
  • Drug: entecavir placebo tablets
    Patients with chronic hepatitis B:Administered Entecavir placebo orally once daily for consecutive 28 days in fasted state
Study Arms  ICMJE
  • Experimental: HEC121120 tablets
    part 1(Health volunteer): single-Dose Study: There will be a total of 6 dose cohorts: 25 mg、50 mg、100 mg、400 mg、600 mg、800 mg food effect:200 mg multiple-dose study: 200 mg part 2(Patients with chronic hepatitis B): There will be a total of 3 dose cohorts:100、200、400 mg
    Intervention: Drug: HEC121120 tablets
  • Placebo Comparator: HEC121120 placebo tablets
    part 1(Health volunteer): single-Dose Study: There will be a total of 6 dose cohorts: 25 mg、50 mg、100 mg、400 mg、600 mg、800 mg food effect:200 mg multiple-dose study: 200 mg part 2(Patients with chronic hepatitis B): There will be a total of 3 dose cohorts:100、200、400 mg
    Intervention: Drug: HEC121120 placebo tablets
  • Active Comparator: entecavir tablets
    part 2(Patients with chronic hepatitis B): 0.5 mg
    Intervention: Drug: entecavir tablets
  • Placebo Comparator: entecavir placebo tablets
    part 2(Patients with chronic hepatitis B): 0.5 mg
    Intervention: Drug: entecavir placebo tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2020)
126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2022
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Health volunteer

Inclusion Criteria:

  1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
  2. Be able to complete the study according to the trail protocol.
  3. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
  4. subjects and must be 18 to 45 years of age inclusive.
  5. Body weight ≥ 45 kg and body mass index(BMI)between 18 and 28 kg / m^2, inclusive.
  6. Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

  1. Use of >5 cigarettes per day during the past 3 months.
  2. Known history of allergy to study drugs,or allergies constitution ( multiple drug and food allergies).
  3. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
  4. Donation or loss of blood over 450 mL within 3 months prior to screening. 5.12-lead ECG with clinically significant.

6.Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis. 7.Subjects deemed unsuitable by the investigator for any other reason.

Patients with chronic hepatitis B

Inclusion Criteria:

  1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
  2. Be able to complete the study according to the trail protocol.
  3. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
  4. subjects and must be 18 to 65 years of age inclusive.
  5. Body mass index(BMI)between 18 and 32 kg / m^2, inclusive.
  6. There is evidence of hepatitis B infection for more than 6 months。
  7. HBV DNA copies≥2.0×10^4 IU/mL.
  8. ALT≤5×ULN,TBIL≤2×ULN
  9. No cirrhosis.

Exclusion Criteria:

  1. Use of >5 cigarettes per day during the past 3 months.
  2. Known history of allergy to study drugs,or allergies constitution ( multiple drug and food allergies).
  3. Female subjects were lactating or had positive serum pregnancy results during the screening or testing period.
  4. Donation or loss of blood over 450 mL within 3 months prior to screening. 5.12-lead ECG with clinically significant.

6.Positive for Viral hepatitis C, HIV and syphilis. 7. AFP>50 ng/mL. 8. eGFR<60 mL/min/1.73m^2 9.Subjects deemed unsuitable by the investigator for any other reason.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yanhua Ding, Doctor 18186879768 dingyanhua2003@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04536532
Other Study ID Numbers  ICMJE HEC121120-P-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunshine Lake Pharma Co., Ltd.
Study Sponsor  ICMJE Sunshine Lake Pharma Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sunshine Lake Pharma Co., Ltd.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP