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

• Status: Recruiting
• Trial end date: 2022-09-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

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.