Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmac… (NCT04536532) | Clinical Trial Compass
TerminatedPhase 1/2
Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of â… Phase of Study
Stopped: Company decision to discontinue trial
China52 participantsStarted 2020-10-09
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
. 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.