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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673567
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

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

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Study Type : Interventional  (Clinical Trial)
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 : March 31, 2016
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : February 10, 2017

Arm Intervention/treatment
Experimental: TEV-48125 - 1
Dose Regimen 1
Drug: TEV-48125 - 1
Subcutaneous administration Dose Regimen 1
Other Name: monoclonal antibody

Experimental: TEV-48125 - 2
Dose Regimen 2
Drug: TEV-48125 - 2
Subcutaneous administration Dose Regimen 2
Other Name: monoclonal antibody

Experimental: TEV-48125 - 3
Dose Regimen 3
Drug: TEV-48125 - 3
Subcutaneous administration Dose Regimen 3
Other Name: monoclonal antibody

Placebo Comparator: Placebo
Matching Placebo
Drug: Placebo
Matching Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673567


Locations
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United States, California
Teva Investigational Site 13529
Glendale, California, United States, 91206
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
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Responsible Party: Teva Pharmaceutical Industries, Ltd.
ClinicalTrials.gov Identifier: NCT02673567    
Other Study ID Numbers: TV48125-PK-10078
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents