A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection

Laborértékek

• Subjects were excluded from the study if one or more of the following criteria were applicable
  • Participants with history of drug allergy or specific allergy;
  • Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems;
  • Participants with history of active pathological bleeding, or bleeding tendency;
  • Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians;
  • Participants with significant liver fibrosis or cirrhosis;
  • Participants with symptoms or a history of hepatic decompensation;
  • Participants with a history or suspected risk of liver cancer;

• Subjects were eligible for inclusion into the study if they met each of the following criteria:
  • Patient with CHB；
  • Male subjects weighed ≥ 45.0 kg, female subjects weighed ≥ 40.0 kg, with a body mass index (BMI) between 19.0 and 30.0 kg/m\^2 (inclusive);
  • Chronic HBV infection for >/= 6 months;
  • The quantitation level of HBsAg was > 100 IU/mL and <3000 IU/mL; The quantitation level of HBV DNA <LLOQ;
  • On Nas therapy for >/= 6 months at the time of screening；
  • Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;