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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

ConditionHepatitis B Virus Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGigaGen, Inc.

About this trial

The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hepatitis B envelope antigen (HBeAg) negative chronic HBV infection for ≥ 6 months, defined as presence of Hepatitis B surface antigen (HBsAg) in serum for ≥ 6 months.

Serum HBsAg concentration between ≥ 100 international units per milliliter (IU/mL) and 2000 IU/mL at screening.

Currently on stable dose of nucleot(s)ide analogues (NAs) (≥ 6 months) and expected to continue while participating in the study, or are not received NAs.

Have serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening (for those who are on NAs); or have serum HBV DNA concentration ≤ 2000 IU/mL at screening (for those who are NOT on NAs).

Disqualifiers

Positive for co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), and/or hepatitis D virus (HDV) at screening.

Participants that weigh less than 50 kilograms (kg) and/or have a body mass index (BMI) less than 18.5.

History of documented liver cirrhosis at screening. Patients under liver cirrhosis evaluation at screening will not be eligible until cirrhosis is ruled out.

Liver stiffness > 8 kilopascal (kPa) at screening.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GIGA-2339

    Drug

    Administered by intravenous infusion

  • Placebo

    Drug

    Administered by intravenous infusion

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Part 1: Single Ascending Dose (SAD)Experimental treatment 2 interventions
Group B: Part 2: Multiple Ascending Dose (MAD)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

SAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
SAD: Up to Day 105; MAD: Up to Day 245

Secondary outcomes

1

SAD and MAD: Maximum Serum Concentration (Cmax) of GIGA-2339

Time frame
SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
2

SAD and MAD: Area Under the Concentration Time Curve (AUC) from 0 to the Last Quantifiable Concentration (AUC0-t) of GIGA-2339

Time frame
SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
3

SAD: AUC From 0 to Infinity (AUC0-∞) of GIGA-2339

Time frame
Pre-dose and at multiple timepoints post-dose up to Day 105
4

SAD: Dose Normalized Maximum Serum Concentration (DN_Cmax). of GIGA-2339

Time frame
Pre-dose and at multiple timepoints post-dose up to Day 105

Other outcomes

Sponsors and contacts

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

GigaGen, Inc.

Lead sponsor

Source ClinicalTrials.gov
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