To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125

Study Overview
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Brief Summary
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This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single Doses Subcutaneous Administration of TEV-48125 (Doses up to 900 mg) in Japanese and Caucasian Healthy Subjects

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: TEV-48125 - 1
* Drug: TEV-48125 - 2
* Drug: TEV-48125 - 3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: Subject must be a non-naturalized Japanese citizen and hold a Japanese passport Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens Subject has been living outside of Japan for no more than 10 years Additional inclusion criteria for Caucasian subjects: The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities. Additional criteria apply, please contact the investigator for more information Exclusion Criteria: The subject is a woman who is pregnant or lactating The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s) The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing Additional criteria apply, please contact the investigator for more information

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEV-48125 - 1<br>Dose Regimen 1 | Drug: TEV-48125 - 1<br>* Subcutaneous administration Dose Regimen 1<br>* Other names: monoclonal antibody;|
| Experimental: TEV-48125 - 2<br>Dose Regimen 2 | Drug: TEV-48125 - 2<br>* Subcutaneous administration Dose Regimen 2<br>* Other names: monoclonal antibody;|
| Experimental: TEV-48125 - 3<br>Dose Regimen 3 | Drug: TEV-48125 - 3<br>* Subcutaneous administration Dose Regimen 3<br>* Other names: monoclonal antibody;|
| Placebo Comparator: Placebo<br>Matching Placebo | Drug: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |