A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age35-65
SponsorFujian Akeylink Biotechnology Co., Ltd.

About this trial

A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B

Eligibility criteria

Qualifiers

Able to sign the informed consent form,and fully understand the test content, process and possible adverse reactions;

Males and females aged 35-65 ,able to complete research in accordance with test plan requirements;

Participants who have no childbearing plan in next year,and must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 6 months after the last dose of the study;

The weight of male patients shall not be less than 50 kg, and the weight of female patients is not less than 45 kg. Body mass index (BMI = weight (kg)/height 2 (m2)) in the range of 18.0~35.0 kg/m2;

Disqualifiers

Participants with a history of allergy to the any ingredient or excipients of the drug under study;

Patients who cannot tolerate venous blood collection and have a history of needle fainting or blood fainting;

Patients with major trauma or major surgery within 3 months before screening; or plan to have surgery during the study;

Blood donation or blood loss ≥400 mL within 3 months prior to screening, or received blood transfusion; or blood donation or blood loss ≥200 mL within 1 month prior to screening;

Trial design

Treatments tested in this trial

  • GST-HG131
  • Placebo to match GST-HG131

Treatment groups

45 Participants
are divided into 3 treatment groups