Participants with chronic HBV infection will receive multiple doses of ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
Research Site 1
San Francisco, California, United States
Research Site 2
Miami, Florida, United States
Research Site 4
New York, New York, United States
Research Site 6
San Antonio, Texas, United States
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85
Time frame: Baseline, Day 85
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication.
Time frame: From time of informed consent through Day 147 ± 3 days
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)
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50 mg orally as pretreatment antihistamine
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of ARC-520: Apparent Clearance (CL)
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)
Time frame: Through 48 hours post-dosing on Days 1 and 57
Pharmacokinetics of Entecavir or Tenofovir: AUC0-24
Time frame: Through 24 hours post-dosing on Days 1 and 57
Pharmacokinetics of Entecavir or Tenofovir: AUClast
Time frame: Through 24 hours post-dosing on Days 1 and 57
Pharmacokinetics of Entecavir or Tenofovir: Cmax
Time frame: Through 24 hours post-dosing on Days 1 and 57
Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)
Time frame: Through 24 hours post-dosing on Days 1 and 57