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TEV-48125 - 1

Phase 1

Pharmacokinetics | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Dec 13, 2021

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02673567To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125PHASE1 COMPLETED 64 — — Mar 31, 2016Feb 10, 2017Dec 13, 20211 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma drug concentration (Cmax)
33 weeks
Time to maximum observed plasma drug concentration (tmax)
33 weeks
AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)
33 weeks
AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)
33 weeks
AUC from time 0 extrapolated to infinity (AUC0-∞)
33 weeks
Percentage extrapolated AUC (%AUCext)
33 weeks
Apparent serum terminal elimination rate constant (λz)
33 weeks
Apparent total body clearance (CL/F)
33 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
33 weeks
Apparent serum terminal elimination half-life (t½)
33 weeks
Secondary Endpoints
Percentage of Participants with Adverse Events
33 weeks
Tolerability- Percentage of participants who fail to complete the study
33 weeks
Percentage of participants who fail to complete the study due to adverse events
33 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
TEV-48125 - 1EXPERIMENTALDose Regimen 1
TEV-48125 - 2EXPERIMENTALDose Regimen 2
TEV-48125 - 3EXPERIMENTALDose Regimen 3
PlaceboPLACEBO_COMPARATORMatching Placebo
Interventions
NameTypeDescription
TEV-48125 - 1DRUGSubcutaneous administration Dose Regimen 1
TEV-48125 - 2DRUGSubcutaneous administration Dose Regimen 2
TEV-48125 - 3DRUGSubcutaneous administration Dose Regimen 3
PlaceboDRUGMatching Placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * The subject is a man or woman, 18 to 55 years of age, inclusive * The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive * The subjects must be in a good health at screening and check-in Additional inclusion criteria for Japanese subjects: * Subje...

Countries:United States
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