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

NCT06021574 | Completed Phase 1

• 1 other identifier: leadingpharm2019013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (13)

• adverse events

  Incidence, severity and relation to investigational drugs of adverse events

  up to 57 days

• Pharmacokinetics-AUC0-t

  area under the concentration-time curve (AUC) from administration to the last measurable concentration

  up to 57 days

• Pharmacokinetics-AUC0-inf

  AUC extrapolated to infinity

  up to 57 days

• Pharmacokinetics-Cmax

  maximum serum concentration

  up to 57 days

• Pharmacokinetics-Tmax

  time to Cmax

  up to 57 days

• Pharmacokinetics-t1/2

  elimination half-life

  up to 57 days

• Pharmacokinetics-Vz

  volume of distribution

  up to 57 days

• Pharmacokinetics-CLz

  clearance rate

  up to 57 days

• Pharmacokinetics- λz

  elimination rate constant

  up to 57 days

• Pharmacokinetics-MRT0-t

  mean residence time (MRT) from administration to the last measurable concentration (MRT0-t)

  up to 57 days

• Pharmacokinetics-MRT0-inf

  MRT extrapolated to infinity

  up to 57 days

• Anti-Drug antibody (ADA)

  Percentage of subjects tested ADA positive.

  up to 57 days

• Neutralizing antibodies (Nab)

  Percentage of subjects tested Nab positive.

  up to 57 days

Study Arms (4)

A single intravenous administration of 1mg VDJ001 or placebo

EXPERIMENTAL

Drug: VDJ001 Drug: Placebo

Drug: VDJ001; Drug: Placebo

A single intravenous administration of 2mg VDJ001 or placebo

EXPERIMENTAL

Drug: VDJ001 Drug: Placebo

Drug: VDJ001; Drug: Placebo

A single intravenous administration of 4mg VDJ001 or placebo

EXPERIMENTAL

Drug: VDJ001 Drug: Placebo

Drug: VDJ001; Drug: Placebo

A single intravenous administration of 8mg VDJ001 or placebo

EXPERIMENTAL

Drug: VDJ001 Drug: Placebo

Drug: VDJ001; Drug: Placebo

Interventions

VDJ001 DRUG

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

A single intravenous administration of 1mg VDJ001 or placebo; A single intravenous administration of 2mg VDJ001 or placebo; A single intravenous administration of 4mg VDJ001 or placebo; A single intravenous administration of 8mg VDJ001 or placebo

Placebo DRUG

Placebo

A single intravenous administration of 1mg VDJ001 or placebo; A single intravenous administration of 2mg VDJ001 or placebo; A single intravenous administration of 4mg VDJ001 or placebo; A single intravenous administration of 8mg VDJ001 or placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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/m2.
• 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.

You may not qualify if:

• 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).
• Alcoholics or those who drink regularly within 3 months before randomization, or those with a positive alcohol breath test.
• Those who smoke within 1 month before screening.
• Those with positive results of nicotine test during screening.
• Drinking excessive amounts of tea, coffee and/or caffeinated beverages every day.
• Positive results of γ interferon release test (T-SPOT).

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Beijing VDJBio Co., LTD.: collaborator

Study Sites (1)

the Affliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Study Officials

• Yu Cao

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials Center of Affiliated Hospital of Qingdao University

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: September 1, 2023
• Study Start: June 28, 2019
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)