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BMS-914143

Phase 1

Chronic Hepatitis B Virus Infection | Monoclonal antibody | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Jun 5, 2013

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

BMS-914143 · 1 trial · 2 indications

Phase 1 1
NCT01708889Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal DysfunctionChronic Hepatitis B Virus Infection
COMPLETED43 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
Chronic Hepatitis B Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
18 time points up to Day 29
Area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration [AUC(0-T)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
18 time points up to Day 29
Maximum observed serum concentration (Cmax) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
18 time points up to Day 29
Apparent volume of distribution (Vz/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
18 time points up to Day 29
Total body clearance (CLT/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
18 time points up to Day 29

Secondary Endpoints

Time to maximum observed serum concentration (Tmax) using serum levels of Lambda
18 time points up to Day 29
Half life (T-HALF) using serum levels of Lambda
18 time points up to Day 29
Immunogenicity assessed by serum levels of anti-Lambda antibodies
5 time points up to Day 43
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)EXPERIMENTALBMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2
Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)EXPERIMENTALBMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2
Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)EXPERIMENTALBMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2
Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)EXPERIMENTALBMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2
Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)EXPERIMENTALBMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR \< 15 mL/min/1.73 m2 (on hemodialysis \[HD\] or non-HD)

Interventions

NameTypeDescription
BMS-914143 (Peginterferon Lambda-1a)BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Normal renal function or mild, moderate, severe or end-stage renal dysfunction Exclusion Criteria: * History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months o...

Countries:United States
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Frequently asked questions about BMS-914143

What is BMS-914143 used for?

BMS-914143 is a monoclonal antibody being developed by Bristol-Myers Squibb for the treatment of chronic Hepatitis B virus infection. It is currently in Phase 1 clinical development as an investigational therapy for this infectious disease indication.

What does BMS-914143 target?

BMS-914143 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied for its potential role in treating chronic Hepatitis B virus infection.

Who makes BMS-914143?

BMS-914143 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research on this investigational monoclonal antibody.

What phase is BMS-914143 in?

BMS-914143 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, and the drug remains in early-stage clinical testing for chronic Hepatitis B virus infection.

What clinical trials is BMS-914143 in?

BMS-914143 has one completed clinical trial, NCT01708889, a pharmacokinetic study in participants with normal renal function and various degrees of renal dysfunction. The study enrolled 43 participants and included patients with chronic Hepatitis B or C virus infection, as well as healthy volunteers.

Is BMS-914143 the same as any other drug?

BMS-914143 is the investigational name used by Bristol-Myers Squibb for this monoclonal antibody. No alternative names have been reported in the available clinical trial information for this drug candidate.