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A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants

ConditionChronic Hepatitis B Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAusper Biopharma Co., Ltd.

About this trial

The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female participants, aged 18-55 years old (inclusive);

Body mass index between 18.0 and 28.0 kg/m² (inclusive);

Laboratory safety tests during the screening period, 12-lead electrocardiogram (ECG), abdominal ultrasound, thyroid ultrasound, chest anteroposterior position, etc., are assessed by the investigatoras normal or abnormal without clinical significance;

Female participants of childbearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening, and must agree to use effective contraceptive methods and refrain from donating eggs from screening until 6 months after the last dose of the study drug.

Disqualifiers

Currently participating in another study, or within 5 half-lives/3 months of the last dose of a previous investigational product.

Presence diseases (cardiovascular, neurological, renal, immunological, metabolic, etc.) or malignant tumors.- Major surgery or severe trauma within the past 6 months.

Acute infection (e.g., influenza, gastroenteritis) within 14 days; vaccination within 28 days prior to screening.

Allergy to any investigational drug component.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AHB-171 Injection

    Drug

    AHB-171 Injection is adminstrated via subcutaneous injection

  • Placebo

    Drug

    Placebo is admistrated via subcutaneous injection

  • Nucleos(t)ide Analogue (NA)

    Drug

    Oral administration

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: AHB-171 and placebo in CHB (Part B: MAD)Experimental treatment 3 interventions
Group B: AHB-171 and placebo in HP(Part A: SAD)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A & Part B Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
PartA:Up to 16 weeks, PartB: Up to 48 weeks
2

Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
PartA:Up to 16 weeks, PartB: Up to 48 weeks
3

Proportion of participants with clinically significant abnormalities in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs

Time frame
PartA:Up to 16 weeks, PartB: Up to 48 weeks
4

Change from baseline in laboratory tests, electrocardiograms (ECGs), physical examinations, and vital signs

Time frame
PartA:Up to 16 weeks, PartB: Up to 48 weeks

Secondary outcomes

1

Part A & Part B:Fraction excreted in urine in percentage for AHB-171

Time frame
Up to Day 3 in Part A; Up to Day 30 in Part B
2

Part A & Part B:Amount excreted in urine for AHB-171

Time frame
Up to Day 3 in Part A; Up to Day 30 in Part B
3

Part A & Part B:Renal clearance for AHB-171

Time frame
Up to Day 3 in Part A; Up to Day 30 in Part B
4

Part A & Part B: Immunogenicity: The number of participants develop anti-drug antibodies (ADA) against AHB-171 and the ADA antibody titer

Time frame
Up to 16 weeks in Part A; Up to 48 weeks in Part B

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ausper Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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