Safety and Tolerability Study of ARC-520 in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01872065

Enrollment

Registered

2013-06-07

Start date

2013-07-31

Completion date

2014-11-30

Last updated

2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.

Interventions

DRUGARC-520

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Healthy male or female subjects, 18-55 years of age * Be a non-smoker Key

Exclusion criteria

* History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination. * Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment. * Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis. * Currently uses and/or has a history of alcohol and/or drug abuse \< 12 months from screening. * Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.

Design outcomes

Primary

Measure	Time frame	Description
To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520	One month	The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group.

Secondary

Measure	Time frame	Description
To evaluate the pharmacokinetics of ARC-520 at different dose concentrations	2 days	Plasma concentrations following a single dose of ARC-520 at different dose levels will be used to calculate the following ARC-520 pharmacokinetic parameters: Cmax, tmax, AUC0-24, AUCinf, and t1/2. Descriptive statistics of pharmacokinetic parameters will include mean, standard deviation, and coefficient of variation.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026