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A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia

NCT01435382 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-07-23

Study results available
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Summary

This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.

Conditions

Interventions

BIOLOGICAL

PF-04950615 (RN316)

Dose A - single-dose intravenous infusion

BIOLOGICAL

PF-04950615 (RN316)

Dose B - single-dose subcutaneous injection

BIOLOGICAL

PF-04950615 (RN316)

Dose C - single-dose subcutaneous injection

BIOLOGICAL

PF-04950615 (RN316)

Dose D - single-dose subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01435382 on ClinicalTrials.gov