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

The Affiliated Hospital of Qingdao University1 site in 1 country40 target enrollmentJune 28, 2019

ConditionsHealthy

InterventionsVDJ001 Placebo

DrugsVDJ001 Placebo

Overview

Phase: Phase 1
Intervention: VDJ001
Conditions: Healthy
Sponsor: The Affiliated Hospital of Qingdao University
Enrollment: 40
Locations: 1
Primary Endpoint: adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 28, 2019

End Date

January 6, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Affiliated Hospital of Qingdao University

Responsible Party

Principal Investigator

Cao Yu

Director of Clinical Trials Center of Affiliated Hospital of Qingdao University

The Affiliated Hospital of Qingdao University

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent form and comply with the protocol to complete the study.
•Age ≥18 years old and ≤45 years old (at the date of signing the informed consent); females weigh between 45.0\~75.0kg, males weigh between 50.0\~80.0kg, the body mass index ( BMI) within the range of 19.0\~26.0kg/m
•Function of heart, liver and kidney is normal.
•The blood pregnancy test for female of childbearing age is negative, and the volunteers or their spouses use appropriate and effective contraceptive measures, such as abstinence, intrauterine device and double barrier method from the test period to 6 months after administration of study drugs.

Exclusion Criteria

•Allergic constitution (e.g. allergic to two or more drugs / foods).
•Those who have a clear history of malignant tumors, neurological or mental disorders (including epilepsy or dementia), heart failure, or immunodeficiency or immunosuppressive diseases, or have undergone major surgery within 6 months before randomization.
•Those with severe bleeding factors that affect venous blood collection or those who are unable/unwilling to receive venipuncture.
•Those who have received any vaccines within 6 months before randomization.
•Those who have previously received anti-IL-6 drugs or other monoclonal antibody treatments, or have used any biological agents within 12 months before randomization.
•Those who have administered with other clinical trial drugs within 3 months before randomization.
•Massive bleeding or whole blood or component blood (\> 400ml) donation within 3 months before randomization.
•With active bacterial, viral, fungal, or parasitic infection or any infection that requires systemic anti-infective treatment within 4 weeks before randomization.
•Those who have received any health products or treated by drugs (including prescription drugs such as warfarin, cyclosporine, theophylline, simvastatin, omeprazole, dextromethorphan, over-the-counter drugs, proprietary Chinese medicine, vitamins, dietary supplements, etc.) within 3 months before randomization or those who may receive drugs during the trial.
•Those who have used soft drugs (such as marijuana) within 3 months before randomization or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial; or those with positive drug abuse test results (cocaine, marijuana, morphine, amphetamine, methamphetamine, phencyclidine, benzodiazepines, barbiturates, methadone and tricyclic antidepressants).