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A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab

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ClinicalTrials.gov Identifier: NCT03919448
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
FP Clinical Pharma S.R.L.
Syngene International Limited
Information provided by (Responsible Party):
Laboratorios Richmond S.A.C.I.F.

Brief Summary:
The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new formulation of Bevacizumab (Zutrab®) when compared to two already marketed formulations Avastin® and Cizumab®, to establish similarity.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Safety Issues Biological: Bevacizumab Phase 1

Detailed Description:

Three-way bridge phase 1 trial. It is conducted in healthy, male adult subjects, it is single-dose, double-blind, parallel groups, randomized and balanced.

Blood samples are collected up to 90 days, to dermine serum drug concentration and anti-drug antibodies. Safety and tolerabilty is also evaluated.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Double-blind, Randomized, Balanced, Parallel Group, Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: Zutrab® (Bevacizumab Richmond)
a single 1 mg/kg IV dose of Bevacizumab
Biological: Bevacizumab
Single-dose infusion

Active Comparator: Avastin®
a single 1 mg/kg IV dose of Bevacizumab
Biological: Bevacizumab
Single-dose infusion

Active Comparator: Cizumab®
a single 1 mg/kg IV dose of Bevacizumab
Biological: Bevacizumab
Single-dose infusion




Primary Outcome Measures :
  1. Peak serum concentration of bevacizumab (Cmax) [ Time Frame: Day 1 to Day 63 ]
    Cmax will be obtained directly from the serum concentration-time curve

  2. Area under the serum concentration-time curve of bevacizumab (ABC0-t) [ Time Frame: Day 1 to Day 63 ]
    Area under the serum concentration-time curve from time zero to the last experimental point, will be calculated by the trapezoidal rule

  3. Area under the serum concentration- time curve ob bevacizumab (ABC0-∞) [ Time Frame: Day 1 to Day 63 ]
    Area under the serum concentration- time curve from time zero to infinity


Secondary Outcome Measures :
  1. Time to reach the peak serum concentration (Tmax) [ Time Frame: Day 1 to Day 63 ]
    Time to reach the peak serum concentration, which will be obtained directly from the serum concentration curve- time

  2. Terminal elimination rate constant (λz) [ Time Frame: Day 1 to Day 63 ]
    Terminal elimination rate constant will be calculated by linear regression analysis of the semi-logarithmic curve

  3. Elimination half life (T1/2) [ Time Frame: Day 1 to Day 63 ]
  4. Systemic Clearance (CL) [ Time Frame: Day 1 to Day 63 ]
  5. Distribution volume [ Time Frame: Day 1 to Day 63 ]
  6. Anti-bevacizumab serum antibodies detection (Immunogenicity) [ Time Frame: Screening and end of study (Day 63) ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: 63 days ]
    Report the nature and incidence of adverse events and the eventual suspension or abandonment of the study or the participation of a study subject.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study subjects must be willing and able to provide written informed consent
  • Subjects of study, volunteers, adults, healthy.
  • Study subjects whose safety and complementary laboratory tests are within normal values or which, in the Investigator's opinion, do not have clinical relevance: blood count, erythrosedimentation, hepatogram, urea, creatinine, glucose, coagulogram, serology for HIV, hepatitis B , hepatitis C, immunogenicity, complete urinalysis, detection of drugs of abuse in urine and electrocardiogram.
  • Body mass index between 19 and 27 kg / m2 at the screening visit.
  • Subjects of study preferably non-smokers.
  • Men with a partner of childbearing age must agree that their partner uses an adequate contraceptive method before entering the study and for at least 3 months after the end of the study. It is understood as a contraceptive method suitable to any hormonal contraceptive method or intrauterine device (which should be established before the start of the study) and the use of a spermicide as a barrier method. The use of a barrier method alone or sexual abstinence is not considered adequate.
  • Subjects must agree not to donate sperm during the study and for 4 months after treatment.

Exclusion Criteria:

  • History of pulmonary, gastrointestinal, hepatic, renal, hematological, endocrine-metabolic, neurological or psychiatric illnesses (depressive disorders, in particular) at the time of taking the anamnesis and the physical examination during the first visit of the Protocol of Clinical research.
  • History of gastrointestinal surgeries (except uncomplicated appendectomy, at least 3 months old).
  • History of major surgery, surgical biopsy and / or history of significant trauma within 1 month of the screening visit.
  • Specifically, pre-existing gastrointestinal conditions such as abdominal fistulas, gastrointestinal perforation within 6 months of the screening visit.
  • Specifically, preexisting gastrointestinal conditions such as acute or subacute intestinal occlusion.
  • Specifically, history of inflammatory bowel disease.
  • History of hemorrhagic diseases and / or coagulopathies and / or thromboembolic events.
  • History of heart and vascular diseases: specifically myocardial infarction, unstable angina, cerebrovascular accident, uncontrolled arterial hypertension and cardiac arrhythmias.
  • Background or current history of alcohol or drug abuse.
  • Blood donation within 3 months prior to selection.
  • Administration of any other drug under investigation or participation in a clinical research trial within 3 months prior to the planned participation in this Clinical Research Protocol.
  • History of clinically significant diseases or disorders that, in the opinion of the Investigator, may impede the participation of the study subject for safety reasons or that may influence the results of the same as well as the ability of the study subject to participate in the Clinical Research Protocol.
  • History of hypersensitivity to bevacizumab and / or any of the excipients.
  • Study subjects who present contraindications to therapy
  • Study subjects who have received (2 weeks before) or are receiving aspirin or clopidogrel
  • The study subjects must have suspended any pharmacological treatments at least 2 weeks before the initiation of this Clinical Research Protocol.
  • Non-cooperative study subjects
  • Study subjects employed by the Researcher or the Clinical-Pharmacokinetic Research Unit, with direct participation in the Clinical Research Protocol or other clinical protocols under the Direction of the Researcher or the Clinical-Pharmacokinetic Research Unit
  • Physical findings and laboratory analyses:
  • Cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, endocrine-metabolic, neurological disease or psychiatric disorder (depressive disorders, in particular)
  • Evidence of ulcers, unhealed wounds or bone fractures.
  • Clinically significant abnormalities in any laboratory analysis, and electrocardiogram
  • Positive serology for HIV, hepatitis B, hepatitis C
  • Positive result in immunogenicity test (serum antibodies anti-bevacizumab)

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): NCT03919448


Contacts
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Contact: Ethel C Feleder, MD +541147752640 efeleder@fpclinicalpharma.com.ar

Locations
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Argentina
FP Clinical Pharma S.R.L. Recruiting
Buenos Aires, Argentina, C1425BAA
Contact: María Verónica Alem Site Coordinator    +541147752640    valem@fpclinicalpharma.com.ar   
Contact: Claudio Servente Regulatory affairs    +541147752640    cservente@fpclinicalpharma.com.ar   
Sponsors and Collaborators
Laboratorios Richmond S.A.C.I.F.
FP Clinical Pharma S.R.L.
Syngene International Limited
Investigators
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Principal Investigator: Ethel C Feleder, MD FP Clinical Pharma S.R.L.

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Responsible Party: Laboratorios Richmond S.A.C.I.F.
ClinicalTrials.gov Identifier: NCT03919448     History of Changes
Other Study ID Numbers: 0221
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Laboratorios Richmond S.A.C.I.F.:
Bevacizumab
Biosimilar
Antineoplasic Agents
Bioequivalence
Inmunogenicity
safety
healthy male volunteers

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