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TEV-48125- 1

Phase 1

Undisclosed | Small molecule | Other |Teva Pharmaceutical Industries Limited|Trials Updated: Dec 13, 2021

TEV-48125- 1 target and mechanism

ModalitySmall molecule

Also known as monoclonal antibody

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

TEV-48125- 1 clinical trials

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- 1?

TEV-48125- 1 is an investigational small molecule developed by Teva Pharmaceutical Industries Limited. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, focused on pharmacokinetics, safety, and tolerability after a single subcutaneous administration. Its specific therapeutic indication has not been disclosed.

Who is developing TEV-48125- 1?

TEV-48125- 1 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 1 study of the compound in healthy subjects.

What phase is TEV-48125- 1 in?

TEV-48125- 1 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound remains investigational and has not been approved by the FDA.

What clinical trial is TEV-48125- 1 in?

TEV-48125- 1 has been evaluated in a single completed Phase 1 trial, NCT02673567. The study assessed pharmacokinetics, safety, and tolerability of a single subcutaneous dose in Japanese and Caucasian healthy subjects. It enrolled 64 participants, was randomized, double blind, and placebo controlled, and was conducted in the United States.

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

Yes, TEV-48125- 1 and TEV-48125 - 1 refer to the same investigational compound from Teva Pharmaceutical Industries Limited. The two spellings differ only by spacing in the designation.