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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

NCT ID: NCT02673567

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TEV-48125 - 1

Dose Regimen 1

Group Type EXPERIMENTAL

TEV-48125 - 1

Intervention Type DRUG

Subcutaneous administration Dose Regimen 1

TEV-48125 - 2

Dose Regimen 2

Group Type EXPERIMENTAL

TEV-48125 - 2

Intervention Type DRUG

Subcutaneous administration Dose Regimen 2

TEV-48125 - 3

Dose Regimen 3

Group Type EXPERIMENTAL

TEV-48125 - 3

Intervention Type DRUG

Subcutaneous administration Dose Regimen 3

Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Interventions

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TEV-48125 - 1

Subcutaneous administration Dose Regimen 1

Intervention Type DRUG

TEV-48125 - 2

Subcutaneous administration Dose Regimen 2

Intervention Type DRUG

TEV-48125 - 3

Subcutaneous administration Dose Regimen 3

Intervention Type DRUG

Placebo

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Intervention Type DRUG

Other Intervention Names

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monoclonal antibody monoclonal antibody monoclonal antibody

Eligibility Criteria

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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


* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 13529

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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TV48125-PK-10078

Identifier Type: -

Identifier Source: org_study_id