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Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Broward Research Group
Hollywood, Florida, 33024 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Healthy male and/or female subjects between the ages of 18 and 65 years

2. Body Mass Index (BMI) 33.0 kg/m2 or lower; and a total body weight 60 to 90 kg (132
198 lbs) inclusive

3. Fasting LDL-C must be 80 to 200 mg/dL at two qualifying visits: initial screening
(Days -28 to -14) and Day -7.

4. Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

5. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Evidence or history of clinically significant disease or other severe acute or chronic
medical or psychiatric condition or laboratory abnormality that may increase the risk
associated with study participation or investigational product administration or may
interfere with the interpretation of study results

2. Any condition possibly affecting drug absorption.

3. Pregnant/breast feeding female subjects; male subjects with partners currently
pregnant; male & female subjects of childbearing potential who are unwilling or unable
to use a highly effective method of contraception

4. History of allergic or anaphylactic reaction to any therapeutic or diagnostic mAb or
molecules made of components of mAb

5. History of regular alcohol consumption : >7 drinks/wk (F) or 14 drinks/wk (M)

6. History of sensitivity to heparin or heparin?induced thrombocytopenia.

7. Positive urine drug screen.

8. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.

9. Screening seated BP of 140/90 mm Hg or higher

10. Screening 12?lead ECG demonstrating QTc >450 or a QRS interval >120 msec

11. Subjects with prior exposure to bococizumab (also known as PF?04950615 or RN316) or
other investigational PCSK9 inhibitors.

12. Treatment with marketed or investigational mAbs within 6 months or 5 half?lives of Day
1

13. Treatment with an investigational drug within 30 days or 5 half?lives of Day 1, and/or
anticipated to take part in a clinical study during the duration of this study.

14. Use of prescription or nonprescription drugs within 7 days or 5 half?lives of Day 1;

15. Abnormal labs:

AST/SGOT or ALT/SGPT greater than or equal to 1.2 × ULN; total bilirubin greater than
or equal to 1.5 × ULN; CK >1.5 × ULN or absolute value >600 U/L.

16. Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol.

17. Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.

NCT02458209
Pfizer
Completed
Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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