NCT06021574

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

A Single Center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of a Novel Recombinant Humanized Anti Interleukin-6 Receptor Monoclonal Antibody in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	VDJ001	a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-06-28
• Primary completion: 2020-01-06
• Completion: 2020-01-06
• First posted: 2023-09-01
• Last updated: 2023-09-01

Locations

1 site across 1 country: China