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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: TEV-48125 - 1; Drug: TEV-48125 - 2; Drug: TEV-48125 - 3; Drug: Placebo

• Registration Number: NCT02673567
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Study Start: 2016-03-31
• Primary Completion: 2016-12-16
• Study Completion: 2017-02-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEV-48125 - 1	TEV-48125 - 1	Dose Regimen 1
TEV-48125 - 2	TEV-48125 - 2	Dose Regimen 2
TEV-48125 - 3	TEV-48125 - 3	Dose Regimen 3
Placebo	Placebo	Matching Placebo

Primary Outcome Measures

Name	Time	Method
Percentage extrapolated AUC (%AUCext)	33 weeks
Apparent serum terminal elimination rate constant (λz)	33 weeks
Maximum observed plasma drug concentration (Cmax)	33 weeks
Time to maximum observed plasma drug concentration (tmax)	33 weeks
AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)	33 weeks
AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)	33 weeks
AUC from time 0 extrapolated to infinity (AUC0-∞)	33 weeks
Apparent total body clearance (CL/F)	33 weeks
Apparent volume of distribution during the terminal phase (Vz/F)	33 weeks
Apparent serum terminal elimination half-life (t½)	33 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events	33 weeks
Tolerability- Percentage of participants who fail to complete the study	33 weeks
Percentage of participants who fail to complete the study due to adverse events	33 Weeks

Trial Locations

Locations (1)

Teva Investigational Site 13529; 🇺🇸 Glendale, California, United States