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A First-in-human Study of a Novel Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody

NCT06021574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-01

No results posted yet for this study

Summary

The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and immunogenicity of investigational drug in healthy subjects. The main questions it aims to answer are:

* Safety and tolerability of investigational drug.
* pharmacokinetics and immunogenicity of investigational drug. Participants will receive a single intravenous administration of investigational drug or placebo. Blood samples are collected at specified time points.

Conditions

  • Healthy

Interventions

DRUG

VDJ001

a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Beijing VDJBio Co., LTD.

    collaborator INDUSTRY

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Yu Cao · The Affiliated Hospital of Qingdao University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2020-01-06
Completion
2020-01-06

Countries

  • China

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 NCT06021574 on ClinicalTrials.gov