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Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase

Last updated on March 14, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Hypercholesterolemia
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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- Healthy and hypercholesterolemic subjects between the ages of 18 and 65 years.

- Healthy subjects must have fasting LDL-C >/= 70 to = 190 mg/dL at two qualifying
visits.

- Hypercholesterolemic subjects must be on a stable daily dose of statin for at least 45
days before dosing and fasting LDL-C must be >/= 70 mg/dL.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Use of prescription or non-prescription drugs within 7 days or 5 half-lives
(whichever) is longer prior to the first dose of study medication. For
hypercholesterolemic subjects the use of statin class medication is allowed.

- Prior exposure to bococizumab (also known as PF-04950615 or RN316) or other
investigational PCSK9 inhibitors.

- Treatment with monoclonal antibodies within 6 months or 5 half-lives (whichever is
longer) before dosing.

NCT02667223
Pfizer
Terminated
Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase

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