A Study of ARC-521 Injection in Normal Adult Volunteers & Patients With

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

Phase 1a/1b multicenter dose-escalation study of ARC-521 Injection in normal healthy volunteers and patients with CHB. Eligible participants who have signed an Ethics Committee (EC)/Institutional Review Board (IRB) approved informed consent form and have met all of the protocol eligibility criteria.

Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate, and temperature), weight, adverse events assessment (AEs), concomitant medications/therapies assessment, electrocardiograms (ECGs), telemetry [NHVs only], measures of hepatic fibrosis [CHBs only], blood sample collection for hematology, coagulation, chemistry, Pharmacokinetics (PK) [NHVs only], metabolic analysis [NHVs only], exploratory Pharmacodynamic (PD) measures, urinalysis, hepatitis B virus (HBV) serology, immunogenicity, Follicle Stimulating Hormone (FSH) testing (post-menopausal females) and pregnancy testing for females of childbearing potential. Clinically significant changes including AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the patient is lost to follow-up. Prior to enrollment there is a 60 day screening period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02797522
Study type	Interventional
Source	Arrowhead Pharmaceuticals
Contact
Status	Terminated
Phase	Phase 1
Start date	June 2016
Completion date	November 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01182311` - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed	`NCT04971928` - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment	Phase 1
Completed	`NCT03285620` - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants	Phase 1
Completed	`NCT01884415` - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis	Phase 3
Recruiting	`NCT05404919` - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates	Phase 2
Completed	`NCT02153320` - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers	Phase 1
Completed	`NCT00352963` - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).	Phase 3
Completed	`NCT03567382` - Arresting Vertical Transmission of Hepatitis B Virus	Phase 4
Not yet recruiting	`NCT04056728` - A Phase IV Study to Assess the Safety of EupentaTM Inj	Phase 4
Not yet recruiting	`NCT03604016` - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver	Phase 4
Completed	`NCT00753649` - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants	Phase 4
Recruiting	`NCT03027258` - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome	N/A
Completed	`NCT02540538` - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders	Phase 1
Terminated	`NCT02604199` - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection	Phase 2
Completed	`NCT02169674` - Hepatitis B Booster Study in Adolescence	Phase 4
Completed	`NCT02421666` - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV	N/A
Completed	`NCT01917357` - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject	Phase 3
Completed	`NCT01732354` - Study for Consolidation Period of Chronic Hepatitis B
Completed	`NCT01368497` - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection	Phase 3
Recruiting	`NCT01462981` - Cohort of Hepatitis B Research of Amsterdam	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms