A SINGLE-DOSE, 2-ARM, PHARMACOKINETIC STUDY OF PF-06439535 (CN) AND EUROPEAN UNION SOURCED BEVACIZUMAB IN CHINESE HEALTHY MALE VOLUNTEERS

NCT04126044 | Withdrawn Phase 1

• 1 other identifier: B7391005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized (1:1), parallel group, single dose, 2-arm, comparative PK study of PF-06439535 (CN) and bevacizumab-EU administered intravenously to Chinese healthy male volunteers. Approximately 66 subjects will be enrolled to ensure that at least 58 subjects (29 per arm) complete the study procedures and have evaluable PK data. The study will be conducted at 1 center in China.

Conditions

Pharmacokinetics

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• AUC0-t (Area under the serum concentration-time profile from time 0 to last time point with quantifiable concentration)

  From Day 1 to Day 71

Secondary Outcomes (9)

• Cmax (Maximum observed concentration derived from serum)

  From Day 1 to Day 71

• AUCinf (Area under the serum concentration-time profile from time zero extrapolated to infinity)

  From Day 1 to Day 71

• terminal half-life (t1/2)

  From Day 1 to Day 71

• clerance (CL)

  From Day 1 to Day 71

• steady state volume of distribution (Vss)

  From Day 1 to Day 71

Study Arms (2)

Reference: bevacizumab - EU

ACTIVE COMPARATOR

Drug: bevacizumab - EU

Test: PF-06439535 (CN)

EXPERIMENTAL

Drug: PF-06439535 (CN)

Interventions

PF-06439535 (CN) DRUG

This is the test drug Pfizer biosimilar of bevacizumab-EU.

Test: PF-06439535 (CN)

bevacizumab - EU DRUG

This is the reference drug bevacizumab sourced from EU

Reference: bevacizumab - EU

Eligibility Criteria

• Age: 21 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese male subjects who, at the time of screening, are between the ages of 21 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12 lead electrocardiogram (ECG), or clinical laboratory tests.
• Subjects must have adequate organ function (excluding subjects who received blood transfusions) according to the following laboratory values: bone marrow function (absolute neutrophil count (ANC) \>=1,500/mm3 and platelet count of 100,000/mm3), adequate liver function (alanine aminotransferase (ALT) \<=3 times upper limit normal and alkaline phosphatase \<= 2 times upper limit normal, total bilirubin \<= 1.5 mg/dl), and adequate renal function (blood urea nitrogen (BUN)/urea \<=1.5 times institutional normal and Creatinine \<1.5 mg/dl) upon study entry.
• Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Evidence or history of heart failure, arterial or venous thromboembolism, bleeding diathesis, acquired coagulopathy or coagulopathy factor abnormality with international normalized ratio (INR) of \>=1.5, or history of gross hemorrhage within the past 6 months prior to Screening (eg, hemoptysis or hematuria requiring medical intervention).
• Evidence or history of relevant and clinically significant intra abdominal inflammation, gastrointestinal perforation or gall bladder perforation.
• Major surgery or elective surgery within 3 months before or after administration of study treatment. At least 28 days should elapse from the time of minor surgical procedure, including placement of an access device and dental procedures.
• Wounds that have not completely healed, active ulcer(s), or bone fracture(s).
• Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.
• Screening supine BP \>= 140 mm Hg (systolic) or \>= 90 mm Hg (diastolic) on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest. If BP is \>= 140 mm Hg (systolic) or \>= 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
• Clinically significant abnormalities in laboratory test results.
• Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
• Fertile male subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol (refer to Section 4.4.4) for 71 days following study drug administration.
• A positive urine drug test.
• History of febrile illness within 5 days prior to dosing.
• Current use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
• History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months of Screening.
• History of serious allergic or anaphylactic reaction to a therapeutic drug.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 201107, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 14, 2019
• Study Start: January 22, 2021
• Primary Completion: July 10, 2021
• Study Completion: July 10, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)