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CompletedNCT02673567Updated Dec 13, 2021

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 Phase 1 interventional study of TEV-48125 - 1 and TEV-48125 - 2 in Pharmacokinetics, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-13.

Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Dec 2016, 9 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pharmacokinetics
03

In context

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 205 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    TEV-48125 - 1

    Dose Regimen 1

    Drug: TEV-48125 - 1

  • Experimental
    TEV-48125 - 2

    Dose Regimen 2

    Drug: TEV-48125 - 2

  • Experimental
    TEV-48125 - 3

    Dose Regimen 3

    Drug: TEV-48125 - 3

  • Placebo comparator
    Placebo

    Matching Placebo

    Drug: Placebo

Interventions

  • DrugTEV-48125 - 1

    Subcutaneous administration Dose Regimen 1

    Also known as: monoclonal antibody

  • DrugTEV-48125 - 2

    Subcutaneous administration Dose Regimen 2

    Also known as: monoclonal antibody

  • DrugTEV-48125 - 3

    Subcutaneous administration Dose Regimen 3

    Also known as: monoclonal antibody

  • DrugPlacebo

    Matching Placebo

06

What researchers measure

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

07

Study locations

1 site
  • Teva Investigational Site 13529
    Glendale, California 91206, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02673567
Lead sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Responsible party
Sponsor
First posted
Feb 4, 2016
Start date
Mar 31, 2016
Primary completion
Dec 16, 2016
Completion
Feb 10, 2017
Last update
Dec 13, 2021

Study contacts

Teva Medical Expert, MD
study director · Teva Branded Pharmaceutical Products R&D, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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