A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
NCT03762681 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2021-05-11
Summary
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B (CHB).
Conditions
- Hepatitis B Virus Infection
Interventions
- DRUG
-
RO7239958
Solution for injection, subcutaneous use (SC).
- OTHER
-
Placebo
Sodium chloride solution for injection, SC
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-14
- Primary Completion
- 2020-04-06
- Completion
- 2020-04-06
Countries
- Bulgaria
- Hong Kong
- New Zealand
- Poland
- South Korea
- Taiwan
- United Kingdom
Study Locations
More Related Trials
-
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
NCT02952924 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II)
NCT02662712 ·Status: COMPLETED ·Phase: PHASE1
-
Study of the Efficacy and Safety of HS-10234 in Patients With Chronic Hepatitis B Virus Infection
NCT03903796 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
NCT04667104 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
NCT03982186 ·Status: COMPLETED ·Phase: PHASE2
-
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
NCT02908191 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
NCT04225715 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating AHB-137 in Healthy Participants and Participants with Chronic Hepatitis B
NCT05717686 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
NCT04585789 ·Status: COMPLETED ·Phase: PHASE2
-
A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
NCT04971512 ·Status: TERMINATED ·Phase: PHASE1
-
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
NCT04454567 ·Status: TERMINATED ·Phase: PHASE2
-
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
NCT05275023 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection
NCT05005507 ·Status: TERMINATED ·Phase: PHASE2
-
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
NCT02496897 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
NCT04398134 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
NCT01026610 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection
NCT03361956 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
NCT03714152 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of LW231 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
NCT06311734 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
NCT05414981 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients
NCT04480294 ·Status: UNKNOWN ·Phase: PHASE1
-
Pegasys Plus Entecavir Versus Entecavir Versus Pegasys for Hepatitis B e Antigen-Negative Chronic Hepatitis B
NCT01925820 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
NCT05123599 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
NCT04129554 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
NCT02797522 ·Status: TERMINATED ·Phase: PHASE1