Stopped: Company decision to discontinue trial
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo. The maximum study duration for NHVs is approximately 21 weeks. Hepatitis B e Antigen (HBeAg)-negative participants with (CHB) will enroll sequentially into 3 dose levels (8 patients per dose level) to receive multiple doses of open label ARC-521 Injection. For each CHB participant the maximum study duration is approximately 37 weeks.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
Timeframe: From first dose of study drug through Day 29 (± 1 day)
Number of Participants With TEAEs: CHB Participants
Timeframe: From first dose of study drug through Day 142 (± 3 days)
Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0-24 Hours (AUC0-24), Healthy Volunteers
Timeframe: Through 48 hours post-dose on Day 1
Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Healthy Volunteers
Timeframe: Through 48 hours post-dose on Day 1
Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Healthy Volunteers
Timeframe: Through 48 hours post-dose on Day 1
Pharmacokinetics of ARC-521 Injection: Maximum Observed Plasma Concentration (Cmax), Healthy Volunteers
Timeframe: Through 48 hours post-dose on Day 1
Pharmacokinetics of ARC-521 Injection: Clearance (CL), Healthy Volunteers
Timeframe: Through 48 hrs post-dose on Day 1
Pharmacokinetics of ARC-521 Injection: Apparent Volume of Distribution (V), Healthy Volunteers
Timeframe: Through 48 hours post-dose on Day 1
Pharmacokinetics of ARC-521 Injection: Terminal Elimination Rate Constant (Kel), Healthy Volunteers
Timeframe: Through 48 hours post-dose on Day 1
Pharmacokinetics of ARC-521 Injection: Terminal Elimination Half-Life (t1/2), Healthy Volunteers
Timeframe: Through 48 hours post-dose on Day 1
Change Over Time in Viral Antigens and DNA in CHB Participants as a Measure of Activity of ARC-521 Injection
Timeframe: Baseline to Day 142