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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-12-31

Brief Summary

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This is an open label, single dose, randomized, parallel group study in healthy adult subjects to assess the comparability of bococizumab administered in a prefilled syringe vs. prefilled pen and comparability between drug substance manufactured at Pfizer Andover vs. Boehringer Ingelheim Pharma.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Pfizer Andover

Group Type ACTIVE_COMPARATOR

bococizumab PFS:Pfizer

Intervention Type BIOLOGICAL

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover

Treatment B

• Treatment B: 150 mg SC dose administered in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma

Group Type EXPERIMENTAL

bococizumab PFS: BIP

Intervention Type BIOLOGICAL

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.

Treatment C

150 mg SC dose administered in a prefilled pen using drug substance manufactured at Pfizer Andover.

Group Type EXPERIMENTAL

bococizumab PFP

Intervention Type BIOLOGICAL

150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover

Interventions

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bococizumab PFS:Pfizer

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover

Intervention Type BIOLOGICAL

bococizumab PFS: BIP

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.

Intervention Type BIOLOGICAL

bococizumab PFP

150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes