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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	TEV-48125 - 1	Subcutaneous administration Dose Regimen 1
DRUG	TEV-48125 - 2	Subcutaneous administration Dose Regimen 2
DRUG	TEV-48125 - 3	Subcutaneous administration Dose Regimen 3
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2016-03-31
• Primary completion: 2016-12-16
• Completion: 2017-02-10
• First posted: 2016-02-04
• Last updated: 2021-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study