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

Last updated on January 25, 2020

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Descriptive Information
Brief Title  ICMJE Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase
Official Title  ICMJE A Phase 1, Open Label, Randomized, Single Dose, Dose Escalation Study To Assess The Subcutaneous Pharmacokinetics And Pharmacodynamics Of Bococizumab (pf 04950615) Alone And In Co Mixture With Recombinant Human Hyaluronidase (rhuph20, Pf 06744547) In Healthy And Hypercholesterolemic Adult Subjects
Brief Summary This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Hypercholesterolemia
Intervention  ICMJE
  • Biological: Cohort 1: bococizumab 150 mg + rHuPH20
    bococizumab 150 mg + rHuPH20 administered SC to healthy volunteers
  • Biological: Cohort 2: bococizumab 300 mg
    bococizumab 300 mg administered SC to healthy volunteers
  • Biological: Cohort 3: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg + rHuPH20 administered SC to healthy volunteers
  • Biological: Cohort 5: bococizumab 450 mg + rHuPH20
    bococizumab 450 mg + rHuPH20 administered SC to healthy volunteers
  • Biological: Cohort 4: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg + rHuPH20 administered SC to subjects with hypercholesterolemia receiving a statin
Study Arms  ICMJE
  • Experimental: Cohort 1: bococizumab 150 mg + rHuPH20
    bococizumab 150 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 1: bococizumab 150 mg + rHuPH20
  • Active Comparator: Cohort 2: bococizumab 300 mg
    bococizumab 300 mg administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 2: bococizumab 300 mg
  • Experimental: Cohort 3: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 3: bococizumab 300 mg + rHuPH20
  • Experimental: Cohort 5: bococizumab 450 mg + rHUPH20
    bococizumab 450 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers
    Intervention: Biological: Cohort 5: bococizumab 450 mg + rHuPH20
  • Experimental: Cohort 4: bococizumab 300 mg + rHuPH20
    bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to subjects with hypercholesterolemia receiving a statin
    Intervention: Biological: Cohort 4: bococizumab 300 mg + rHuPH20
Publications * Bass A, Plotka A, Mridha K, Sattler C, Kim AM, Plowchalk DR. Pharmacokinetics, pharmacodynamics, and safety of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, in healthy subjects when administered in co-mixture with recombinant human hyaluronidase: A phase 1 randomized trial. Health Sci Rep. 2018 Jul 18;1(9):e61. doi: 10.1002/hsr2.61. eCollection 2018 Sep.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2016)
75
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy and hypercholesterolemic subjects between the ages of 18 and 65 years.
  • Healthy subjects must have fasting LDL-C >/= 70 to
  • 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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667223
Other Study ID Numbers  ICMJE B1481051
2015-003568-36 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Halozyme Therapeutics
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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