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
Overview
- Phase
- Phase 1
- Intervention
- TEV-48125 - 1
- Conditions
- Pharmacokinetics
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Percentage extrapolated AUC (%AUCext)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
TEV-48125 - 1
Dose Regimen 1
Intervention: TEV-48125 - 1
TEV-48125 - 2
Dose Regimen 2
Intervention: TEV-48125 - 2
TEV-48125 - 3
Dose Regimen 3
Intervention: TEV-48125 - 3
Placebo
Matching Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage extrapolated AUC (%AUCext)
Time Frame: 33 weeks
Apparent serum terminal elimination rate constant (λz)
Time Frame: 33 weeks
Maximum observed plasma drug concentration (Cmax)
Time Frame: 33 weeks
Time to maximum observed plasma drug concentration (tmax)
Time Frame: 33 weeks
AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)
Time Frame: 33 weeks
AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)
Time Frame: 33 weeks
AUC from time 0 extrapolated to infinity (AUC0-∞)
Time Frame: 33 weeks
Apparent total body clearance (CL/F)
Time Frame: 33 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Time Frame: 33 weeks
Apparent serum terminal elimination half-life (t½)
Time Frame: 33 weeks
Secondary Outcomes
- 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)