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OpenTrials
Completed

NCT Number: NCT02673567

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 13529

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEV-48125 - 1

Drug

Subcutaneous administration Dose Regimen 1

Other names: monoclonal antibody

TEV-48125 - 2

Drug

Subcutaneous administration Dose Regimen 2

Other names: monoclonal antibody

TEV-48125 - 3

Drug

Subcutaneous administration Dose Regimen 3

Other names: monoclonal antibody

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Maximum observed plasma drug concentration (Cmax)

    Time frame: 33 weeks

  2. Time to maximum observed plasma drug concentration (tmax)

    Time frame: 33 weeks

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

    Time frame: 33 weeks

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

    Time frame: 33 weeks

  5. AUC from time 0 extrapolated to infinity (AUC0-∞)

    Time frame: 33 weeks

  6. Percentage extrapolated AUC (%AUCext)

    Time frame: 33 weeks

  7. Apparent serum terminal elimination rate constant (λz)

    Time frame: 33 weeks

  8. Apparent total body clearance (CL/F)

    Time frame: 33 weeks

  9. Apparent volume of distribution during the terminal phase (Vz/F)

    Time frame: 33 weeks

  10. Apparent serum terminal elimination half-life (t½)

    Time frame: 33 weeks

Secondary outcomes

  1. Percentage of Participants with Adverse Events

    Time frame: 33 weeks

  2. Tolerability- Percentage of participants who fail to complete the study

    Time frame: 33 weeks

  3. Percentage of participants who fail to complete the study due to adverse events

    Time frame: 33 Weeks

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 4, 2016
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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