Study of GST-HG131&141 Tablets Compared With Placebo 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/GST-HG141 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 years(inclusive),able to complete research in accordance with test plan requirements.

Participants who have no childbearing plan in a 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.

Male body weight ≥ 50 kg, female body weight ≥ 45 kg, with a body mass index (BMI) of 18-30 kg/m2 (inclusive).

Disqualifiers

Participants with a history of allergy to any component of the investigational product, or allergic diathesis (allergies to multiple drugs and foods).

Participants unable to tolerate venous blood collection, or with a history of needle syncope or blood phobia.

Participants who sustained major trauma or underwent major surgery within 3 months prior to screening, or those planning to undergo surgery during the study period.

Participants with a history of alcohol abuse (defined as alcohol intake >14 standard units per week; one standard unit equals 350 mL beer, 120 mL wine, or 30 mL spirits with 40% alcohol by volume) or drug abuse/dependence at screening.

Trial design

Treatments tested in this trial

  • GST-HG141
  • GST-HG131
  • GST-HG141 Placebo

Treatment groups

80 Participants
are divided into 3 treatment groups