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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01708889Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal DysfunctionPHASE1 COMPLETED 43 — — Sep 1, 2012Feb 1, 2013Jun 5, 20133 United States
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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 — 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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