Pharmacokinetics
Conditions
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.
Interventions
DRUGTEV-48125 - 1
Subcutaneous administration Dose Regimen 1
DRUGTEV-48125 - 2
Subcutaneous administration Dose Regimen 2
DRUGTEV-48125 - 3
Subcutaneous administration Dose Regimen 3
DRUGPlacebo
Matching Placebo
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apparent serum terminal elimination half-life (t½) | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of Participants with Adverse Events | 33 weeks |
Countries
United States
Outcome results
None listed