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TEV-48125- 1

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

TEV-48125- 1 · 1 trial · 1 indication

Phase 1 1
NCT02673567To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125Pharmacokinetics
COMPLETED64 Analytics
PHASE1COMPLETED
To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125
PharmacokineticsUnlock trial analytics

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 to 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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Frequently asked questions about TEV-48125- 1

What is TEV-48125 used for?

TEV-48125 is an investigational small molecule being studied for pharmacokinetics. It is in Phase 1 clinical development, with a completed trial assessing its pharmacokinetics, safety, and tolerability in healthy subjects. It is not approved and remains in clinical development.

Who makes TEV-48125?

TEV-48125 is being developed by Teva Pharmaceutical Industries Limited, traded on the New York Stock Exchange under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers.

What phase is TEV-48125 in?

TEV-48125 is in Phase 1 clinical development. One Phase 1 trial has been completed, which studied the drug's pharmacokinetics, safety, and tolerability. The drug is investigational and has not been approved.

What clinical trials is TEV-48125 in?

TEV-48125 has one completed clinical trial, NCT02673567, which assessed pharmacokinetics, safety, and tolerability after a single subcutaneous administration in Japanese and Caucasian healthy subjects. The trial enrolled 64 participants in the United States.

Is TEV-48125 the same as TEV-48125-1?

TEV-48125 and TEV-48125-1 refer to the same drug candidate. The clinical trial NCT02673567 uses the name TEV-48125, and the drug is also identified as TEV-48125-1 in development records.