A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers

NCT03576651 | Completed Phase 1 DMC

• 1 other identifier: JHL-CLIN-1149-01
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, Double-blind, Randomized, Parallel-group, Single-dose, Three-Arm Study to Compare the Pharmacokinetics and to Evaluate the Tolerability, Safety and Immunogenicity of JHL1149 and Bevacizumab (Avastin) Sourced from the European Union (EU) and the Union States (US) in Healthy Male Volunteers

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (1)

• AUC0-inf

  area under the concentration-time curve from time zero to infinity (AUC0-inf)

  up to 71 days

Secondary Outcomes (2)

• AUClast

  up to 71 days

• Cmax

  up to 71 days

Study Arms (3)

JHL1149

EXPERIMENTAL

Biological: JHL1149

US-sourced-Avastin™

ACTIVE COMPARATOR

Biological: Bevacizumab

EU-sourced Avastin™

ACTIVE COMPARATOR

Biological: Bevacizumab

Interventions

JHL1149 BIOLOGICAL

Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion

JHL1149

Bevacizumab BIOLOGICAL

Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion

US-sourced-Avastin™

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers,
• Age range of 21-55 years (inclusive).
• BMI range of 18.0-30.0 kg/m2 (inclusive) and a total body weight \>50 kg.
• Medically healthy subjects with normal organ functions and laboratory values
• Subjects must be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing.
• All intermittent medications including over the counter, herbal and nutriceuticals, must be stopped at least 14 days prior to admission to the clinical research center.
• Ability and willingness to abstain from alcohol 48hrs prior to admission to the clinical research center, and throughout the dosing and evaluation period.
• No significant medical history per the PI judgment.
• ECGs (via 12 lead) showing normalized cumulative sum (NCS) findings per PI judgment
• Ability to provide informed consent for the study.

You may not qualify if:

• Previous treatment with an anti-vascular endothelial growth factor (VEGF) antibody or any other antibody or protein targeting the VEGF receptor or treatment with an immunobiological drug during the last three months.
• Previous history of cancer other than adequately treated basal cell or squamous cell carcinoma of the skin.
• Received blood transfusions and blood donation within 3 months before screening date.
• Resting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg.
• Any other severe physical incapacity.
• Positive serological test for hepatitis B surface antigen or positive antibody for hepatitis C virus or positive antibody for human immunodeficiency virus (type 1 and 2).
• Tuberculosis (TB) or an acute systemic infection; demonstrated by positive QuantiFERON-TB and/or Chest radiograph conducted up to 3 months prior or during the screening visit.
• Major surgery planned for the study duration or cases with major surgery in the past 28 days before screening.
• History of relevant drug and/or food related allergies.
• History of or known hypersensitivity to bevacizumab or other recombinant human or humanized antibodies or inactive ingredients.
• History of alcohol and or drug abuse/addiction.
• Positive alcohol breath test and drug screen for opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines.
• Strenuous exercise 96 hrs prior to admission to the clinical research center.
• Any significant or acute illness within 30 days prior to the expected first dose of study drug.
• Unsuitable veins for infusion and/or venepuncture.

Sponsors & Collaborators

• JHL Biotech, Inc.: lead

Study Sites (1)

MHAT Lyulin EAD

Sofia, 1336, Bulgaria

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 3, 2018
• Study Start: March 24, 2018
• Primary Completion: September 17, 2018
• Study Completion: December 13, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

BU (1)