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A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection

NCT05242445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-07-24

No results posted yet for this study

Summary

The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Cetrelimab

Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.

DRUG

Placebo

Placebo will be administered via SC injection or as an IV infusion.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research and Development, LLC Clinical Trial · Janssen Research and Development LLC

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-05-09
Completion
2023-05-09
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT05242445 on ClinicalTrials.gov