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

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: Placebo; Drug: TEV-48125 - 1; Drug: TEV-48125 - 2; Drug: TEV-48125 - 3

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Teva Investigational Site 13529

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching Placebo	Drug: Placebo; Matching Placebo
Experimental: TEV-48125 - 1; Dose Regimen 1	Drug: TEV-48125 - 1; Subcutaneous administration Dose Regimen 1; Other Names: monoclonal antibody
Experimental: TEV-48125 - 2; Dose Regimen 2	Drug: TEV-48125 - 2; Subcutaneous administration Dose Regimen 2; Other Names: monoclonal antibody
Experimental: TEV-48125 - 3; Dose Regimen 3	Drug: TEV-48125 - 3; Subcutaneous administration Dose Regimen 3; Other Names: monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2016
• Primary Completion (Actual): December 16, 2016
• Study Completion (Actual): February 10, 2017

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Antineoplastic Agents, Immunological
• Other Study ID Numbers: TV48125-PK-10078

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No