Clinical trial
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
Name
HEC121120-P-01
Description
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
Trial arms
Trial start
2020-10-12
Estimated PCD
2023-12-30
Trial end
2023-12-30
Phase
Early phase I
Treatment
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.
Arms:
HEC121120 tablets
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.
Arms:
HEC121120 placebo tablets
entecavir tablets
Patients with chronic hepatitis B：Administered Entecavir orally once daily for consecutive 28 days in fasted state
Arms:
entecavir tablets
entecavir placebo tablets
Patients with chronic hepatitis B：Administered Entecavir placebo orally once daily for consecutive 28 days in fasted state
Arms:
entecavir placebo tablets
Size
126
Primary endpoint
Adverse Events
Time Frame: From Days 1-35
Cmax
Time Frame: Day 1-7
AUC
Time Frame: Day 1-7
HBV DNA
Time Frame: Day 29-35
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}
Updated at
2023-04-12
1 organization
2 products
2 indications
Organization
Sunshine Lake PharmaProduct
HEC121120Indication
Hepatitis BIndication
ChronicProduct
Entecavir