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Trial record 55 of 3094 for:    Area Under Curve AND Healthy

A Trial to Demonstrate the Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03390673
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Prestige Biopharma Pte Ltd

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: HD204 Drug: Avastin Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: 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
Actual Study Start Date : September 19, 2018
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: HD204
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Drug: HD204
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Other Name: Bevacizumab

Active Comparator: EU-licensed Avastin
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Drug: Avastin
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Other Name: Bevacizumab

Active Comparator: US-licensed Avastin
Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Drug: Avastin
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Other Name: Bevacizumab




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Immunogenicity [ Time Frame: Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment) ]
    Incidence of anti-bevacizumab antibodies

  2. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) [ Time Frame: From Day 1 through study completion (Day 95) ]
    Safety and tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 2.
  • 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.
  • Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug or non-prescription drugs (with the exception of paracetamol, which is allowed).
  • Previously received bevacizumab or any product considered to be biosimilar to bevacizumab, or any other antibody or protein targeting VEGF or VEGFR.
  • Unwillingness or inability to comply with the study protocol for any reason.
  • Male subject whose partner is pregnant.
  • History or evidence of a clinically significant disorder (including cardiovascular, cerebrovascular, endocrine or psychiatric), or immunocompromised condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • History of alcohol and/or drug abuse within 12 months of screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390673


Locations
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New Zealand
Auckland Clinical Studies
Auckland, New Zealand, 1010
Christchurch Clinical Studies Trust Ltd
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Prestige Biopharma Pte Ltd
Investigators
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Study Chair: Lisa S Park Prestige Biopharma Pte Ltd

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Responsible Party: Prestige Biopharma Pte Ltd
ClinicalTrials.gov Identifier: NCT03390673     History of Changes
Other Study ID Numbers: Samson-1
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prestige Biopharma Pte Ltd:
randomized
double-blind

Additional relevant MeSH terms:
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Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors