MedTrace Logo

A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531

NCT02956850 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-02-08

Study results available
· View outcomes & findings →

Summary

This sponsor-open, investigator- and participant-blinded, multi-center study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy participants and in participants with chronic hepatitis B. Part I will be conducted in two portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include only healthy volunteers. Part II will commence after completion of the MAD portion of Part I and will include only Chronic Hepatitis B (CHB) participants.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

RO7020531

RO7020531 will be administered as per schedule specified in the respective arm.

OTHER

Placebo

Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2021-06-15
Completion
2021-06-15

Countries

  • Bulgaria
  • Hong Kong
  • Italy
  • Netherlands
  • New Zealand
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956850 on ClinicalTrials.gov