Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

Randomized, Double-blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety , Pharmacokinetics and Pharmacodynamics of BMS-844421 in Healthy Subjects and in Subjects With Elevated Cholesterol

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01082562

Enrollment

Registered

2010-03-08

Start date

2010-04-30

Completion date

2010-07-31

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Hypercholesterolemia

Brief 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).

Interventions

DRUGBMS-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

DRUG0.9% sodium chloride injection solution

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Subjects (SAD) * Healthy Subjects (MAD) with untreated elevated cholesterol * Body Mass Index (BMI) of 18 to 30 kg/m² inclusive * Women who are not of childbearing potential and men, ages 18 to 45

Exclusion criteria

* Any significant acute or chronic medical illness * History of liver or renal disorders * Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration

Design outcomes

Primary

Measure	Time frame
To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations	At the conclusion of the MAD part of the study

Secondary

Measure	Time frame
Assess single and multiple dose pharmacokinetics of BMS-844421	All outcomes will be assessed at the conclusion of the MAD part of the study
Assess the absolute bioavailability of single BMS-844421 SC doses	All outcomes will be assessed at the conclusion of the MAD part of the study
Assess the effects of multiple doses of BMS-844421on lipid components	All outcomes will be assessed at the conclusion of the MAD part of the study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026