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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: bococizumab PFS: BIP; Biological: bococizumab PFP; Biological: bococizumab PFS:Pfizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT02458209

B1481026

Details and patient eligibility

About

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.

Enrollment: 470 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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470 participants in 3 patient groups

Treatment A

Active Comparator group

Description:

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

Treatment:

Biological: bococizumab PFS:Pfizer

Treatment B

Experimental group

Description:

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

Treatment:

Biological: bococizumab PFS: BIP

Treatment C

Experimental group

Description:

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

Treatment:

Biological: bococizumab PFP