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

NCT02667223 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-10-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Halozyme Therapeutics

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02667223 on ClinicalTrials.gov