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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02673567
Collaborator
(none)
64
1
4
10.4
6.2

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
  • Drug: TEV-48125 - 1
  • Drug: TEV-48125 - 2
  • Drug: TEV-48125 - 3
  • Drug: Placebo
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Mar 31, 2016
Actual Primary Completion Date :
Dec 16, 2016
Actual Study Completion Date :
Feb 10, 2017

Arms and Interventions

Arm Intervention/Treatment
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
  • Placebo Comparator: Placebo

    Matching Placebo

    Drug: Placebo
    Matching Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma drug concentration (Cmax) [33 weeks]

    2. Time to maximum observed plasma drug concentration (tmax) [33 weeks]

    3. AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t) [33 weeks]

    4. AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672) [33 weeks]

    5. AUC from time 0 extrapolated to infinity (AUC0-∞) [33 weeks]

    6. Percentage extrapolated AUC (%AUCext) [33 weeks]

    7. Apparent serum terminal elimination rate constant (λz) [33 weeks]

    8. Apparent total body clearance (CL/F) [33 weeks]

    9. Apparent volume of distribution during the terminal phase (Vz/F) [33 weeks]

    10. Apparent serum terminal elimination half-life (t½) [33 weeks]

    Secondary Outcome Measures

    1. Percentage of Participants with Adverse Events [33 weeks]

    2. Tolerability- Percentage of participants who fail to complete the study [33 weeks]

    3. Percentage of participants who fail to complete the study due to adverse events [33 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    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.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT02673567
    Other Study ID Numbers:
    • TV48125-PK-10078
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 13, 2021