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

NCT04536532 | Terminated Phase 1

• 1 other identifier: HEC121120-P-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (4)

• Adverse Events

  Incidence of adverse events

  Time Frame: From Days 1-35

• Cmax

  Maximum plasma concentration of study drugs

  Time Frame: Day 1-7

• AUC

  Maximum plasma concentration of study drugs

  Time Frame: Day 1-7

• HBV DNA

  Hepatitis B virus DNA

  Time Frame: Day 29-35

Study Arms (4)

HEC121120 tablets

EXPERIMENTAL

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

Drug: HEC121120 tablets

HEC121120 placebo tablets

PLACEBO COMPARATOR

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

Drug: HEC121120 placebo tablets

entecavir tablets

ACTIVE COMPARATOR

part 2(Patients with chronic hepatitis B): 0.5 mg

Drug: entecavir tablets

entecavir placebo tablets

PLACEBO COMPARATOR

part 2(Patients with chronic hepatitis B): 0.5 mg

Drug: entecavir placebo tablets

Interventions

HEC121120 tablets DRUG

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.

HEC121120 tablets

HEC121120 placebo tablets DRUG

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.

HEC121120 placebo tablets

entecavir tablets DRUG

Patients with chronic hepatitis B：Administered Entecavir orally once daily for consecutive 28 days in fasted state

entecavir tablets

entecavir placebo tablets DRUG

Patients with chronic hepatitis B：Administered Entecavir placebo orally once daily for consecutive 28 days in fasted state

entecavir placebo tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Use of \>5 cigarettes per day during the past 3 months.
• Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
• 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).
• Donation or loss of blood over 450 mL within 3 months prior to screening. 5.12-lead ECG with clinically significant.
• 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
• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
• Be able to complete the study according to the trail protocol.
• Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
• subjects and must be 18 to 65 years of age inclusive.
• Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive.
• There is evidence of hepatitis B infection for more than 6 months。
• HBV DNA copies≥2.0×10\^4 IU/mL.
• ALT≤5×ULN，TBIL≤2×ULN
• No cirrhosis.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Jilin, Changchun, 130000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: August 28, 2020
• First Posted: September 2, 2020
• Study Start: October 9, 2020
• Primary Completion: March 12, 2023
• Study Completion: March 12, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)