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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • GST-HG131

    Drug

    GST-HG131 will be administered.

  • Placebo to match GST-HG131

    Drug

    Placebo to match GST-HG131 will be administered.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in HBsAg levels

Change from Baseline in HBsAg levels

Time frame
Baseline and up to 56 days(Cohort1 and 2) or 16 weeks(Cohort3)

Secondary outcomes

1

Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs

Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs

Time frame
Up to 56 days(Cohort1 and 2) or 16 weeks(Cohort3)

Other outcomes

Sponsors and contacts

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