A Phase I, Double-blind, Randomised, Single-dose, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects

Prestige Biopharma Limited2 sites in 1 country119 target enrollmentSeptember 19, 2018

ConditionsHealthy Volunteers

InterventionsHD204 Avastin

DrugsHD204 Avastin

Overview

Phase: Phase 1
Intervention: HD204
Conditions: Healthy Volunteers
Sponsor: Prestige Biopharma Limited
Enrollment: 119
Locations: 2
Primary Endpoint: Area under Curve (AUC, Pharmacokinetics)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the pharmacokinetics, as well as to evaluate the safety, tolerability and immunogenicity of HD204, US-Avastin and EU-Avastin in healthy male subjects after intravenous administration of a single dose..

Detailed Description

This is a double-blind, randomized, three-arm, parallel-group, single-dose study. A total of 120 evaluable subjects are required.

Registry

clinicaltrials.gov

Start Date

September 19, 2018

End Date

March 13, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Prestige Biopharma Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-smoking healthy male subjects, 18-50 years old inclusive
•Body Mass index is between 19 to 30 kg/m2, inclusive
•NO history of hypersensitivity or allergic reaction to the active ingredient, murine proteins, or excipients, spontaneous or following drug administration.
•For subjects with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the end of study. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate.
•Subjects must agree not to donate sperm during the study and for 4 months following treatment with the study medication or until scheduled End Of Study (EOS), whichever is longer.
•Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.

Exclusion Criteria

•Clinically significant abnormalities in physical examination, laboratory test results or electrocardiogram (ECG)
•Systolic blood pressure \> 140 mmHg or \< 90 mmHg , or diastolic blood pressure \> 90 mmHg or \<50 mmHg
•Proteinuria (with a urine dipstick value of 2+ or above)
•Coagulation abnormalities ( i.e., INR \> 2x ULN)
•Bleeding diathesis, history of duodenal ulcers, concomitant use of anticoagulants, or any hemorrhage within 6 months prior to study enrollment.
•Surgical procedure within 2 months of screening, or planned surgical procedure within 2 months of EOS
•Positive test result for drugs of abuse or alcohol breathing test.
•Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 or
•Donated or lost \> 500ml of blood in the previous 3 months
•Taken an investigational drug within 3 months (or 5 half-lives), whichever is longer.

Arms & Interventions

HD204

Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Intervention: HD204

EU-licensed Avastin

Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Intervention: Avastin

US-licensed Avastin

Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Intervention: Avastin

Outcomes

Primary Outcomes

Area under Curve (AUC, Pharmacokinetics)

Time Frame: up to week 12

Sampling will be performed in all patients to compare the PK through values of HD204 and Avastin

Secondary Outcomes

Immunogenicity(Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment))
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)(From Day 1 through study completion (Day 95))