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A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT03576651•JHL Biotech, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

21 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

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

Exclusion Criteria

•1. 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.
•2. Previous history of cancer other than adequately treated basal cell or squamous cell carcinoma of the skin.
•3. Received blood transfusions and blood donation within 3 months before screening date.
•4. Resting blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg.
•5. Any other severe physical incapacity.
•6. 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).
•7. 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.
•8. Major surgery planned for the study duration or cases with major surgery in the past 28 days before screening.
•9. History of relevant drug and/or food related allergies.
•10. History of or known hypersensitivity to bevacizumab or other recombinant human or humanized antibodies or inactive ingredients.
+8 more criteria

Locations (1)

MHAT Lyulin EAD

Sofia, Bulgaria

Key Dates

Start Date

March 24, 2018

Primary Completion Date

September 17, 2018

Completion Date

December 13, 2019

Last Updated

January 7, 2020

Enrollment

154

ACTUAL participants

Conditions

Healthy Male Subjects

Interventions

JHL1149

BIOLOGICAL

Bevacizumab

BIOLOGICAL

Bevacizumab

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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