Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEV-48125 - 1 | Experimental | Dose Regimen 1 |
|
| TEV-48125 - 2 | Experimental | Dose Regimen 2 |
|
| TEV-48125 - 3 | Experimental | Dose Regimen 3 |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEV-48125 - 1 | Drug | Subcutaneous administration Dose Regimen 1 |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Additional inclusion criteria for Japanese subjects:
Additional inclusion criteria for Caucasian subjects:
The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 13529 | Glendale | California | 91206 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| TEV-48125 - 2 | Drug | Subcutaneous administration Dose Regimen 2 |
|
|
| TEV-48125 - 3 | Drug | Subcutaneous administration Dose Regimen 3 |
|
|
| Placebo | Drug | Matching Placebo |
|
| 33 Weeks |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided