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) in Healthy Male Volunteers

JHL Biotech, Inc.1 site in 1 country154 target enrollmentMarch 24, 2018

ConditionsHealthy Male Subjects

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Male Subjects
Sponsor: JHL Biotech, Inc.
Enrollment: 154
Locations: 1
Primary Endpoint: AUC0-inf
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 24, 2018

End Date

December 13, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

JHL Biotech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.