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A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients

A Multiple-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose, Adaptive Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Subjects and Chronic Hepatitis B Patients

NCT02604355•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral administration in healthy participants and chronic hepatitis B patients.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A Body Mass Index (BMI) between 18 to 30 kg/m\^2, inclusive, and a body weight of at least 50 kg
•Males must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm during the study
•Women should be of non-childbearing potential
•Able to comply with study restrictions
•Non-smoker (nor tobacco-containing products) for at least 90 days prior to dosing on Day 1 and agreeing not to smoke during the study
•Chronic hepatitis B infection
•A BMI between 18 to 32 kg/m\^2, inclusive
•Positive test for HBsAg for more than 6 months prior to randomization
•On entecavir or tenofovir treatment for at least 6 months prior to randomization and remaining on stable treatment during the study
•Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic hepatitis B (HBV) infection without evidence of bridging fibrosis or cirrhosis
+2 more criteria

Exclusion Criteria

•Women who are lactating
•Any suspicion or history of alcohol and/or other substance abuse or dependence in the past 6 months
•Positive urine drug and alcohol screen (barbiturates, benzodiazepines, methadone, amphetamines, methamphetamines, opiates, cocaine, cannabinoids, and alcohol), or positive cotinine test at Day -1
•Positive result on HBV, hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2
•A personal history of unexplained blackouts or faints, or known risk factors for Torsade de Pointes
•Clinically significant abnormalities (as judged by the Investigator) in the physical examination and in the laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) at screening and on Day -1
•Participation in an investigational drug or device study within 90 days prior to screening or 5 times the half-life of the investigational drug (whichever is longer)
•Donation of blood over 500 mL within three months prior to screening
•Concomitant disease or condition (including allergic reactions against any drug, or multiple allergies) that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the healthy participant in this study
•Women who are pregnant (positive pregnancy test) or lactating
+8 more criteria

Locations (4)

Queen Mary Hospital

Hong Kong, Hong Kong

Auckland Clinical Studies Limited

Grafton, New Zealand

Tauranga Hospital

Tauranga, New Zealand

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Key Dates

Start Date

November 28, 2015

Primary Completion Date

May 9, 2016

Completion Date

May 9, 2016

Last Updated

May 25, 2017

Enrollment

ACTUAL participants

Conditions

Hepatitis B, Chronic

Interventions

Matching Placebo

OTHER

RO7020322

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

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RECRUITING

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

NCT06550622

Hepatitis B, Chronic

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RECRUITINGEARLY_PHASE1

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels