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 Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TEV-48125 - 1 Dose Regimen 1 |
Drug: TEV-48125 - 1
Subcutaneous administration Dose Regimen 1
Other Names:
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Experimental: TEV-48125 - 2 Dose Regimen 2 |
Drug: TEV-48125 - 2
Subcutaneous administration Dose Regimen 2
Other Names:
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Experimental: TEV-48125 - 3 Dose Regimen 3 |
Drug: TEV-48125 - 3
Subcutaneous administration Dose Regimen 3
Other Names:
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Placebo Comparator: Placebo Matching Placebo |
Drug: Placebo
Matching Placebo
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject is a man or woman, 18 to 55 years of age, inclusive
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The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive
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The subjects must be in a good health at screening and check-in
Additional inclusion criteria for Japanese subjects:
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Subject must be a non-naturalized Japanese citizen and hold a Japanese passport
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Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens
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Subject has been living outside of Japan for no more than 10 years
Additional inclusion criteria for Caucasian subjects:
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The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.
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Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
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The subject is a woman who is pregnant or lactating
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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)
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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
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Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing
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Additional criteria apply, please contact the investigator for more information
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Teva Investigational Site 13529 | Glendale | California | United States | 91206 |
Sponsors and Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
- Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TV48125-PK-10078