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Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

NCT01082562 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-01-26

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).

Conditions

Interventions

DRUG

BMS-844421

Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days

DRUG

0.9% sodium chloride injection solution

Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Germany

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 NCT01082562 on ClinicalTrials.gov