Overview

This trial is active, not recruiting.

Condition pharmacokinetics
Treatments tev-48125 - 1, tev-48125 - 2, tev-48125 - 3, placebo
Phase phase 1
Sponsor Teva Pharmaceutical Industries, Ltd.
Start date March 2016
End date December 2016
Trial size 64 participants
Trial identifier NCT02673567, TV48125-PK-10078

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Arm
(Experimental)
Dose Regimen 1
tev-48125 - 1 monoclonal antibody
Subcutaneous administration Dose Regimen 1
(Experimental)
Dose Regimen 2
tev-48125 - 2 monoclonal antibody
Subcutaneous administration Dose Regimen 2
(Experimental)
Dose Regimen 3
tev-48125 - 3 monoclonal antibody
Subcutaneous administration Dose Regimen 3
(Placebo Comparator)
Matching Placebo
placebo
Matching Placebo

Primary Outcomes

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

Secondary Outcomes

Measure
Percentage of Participants with Adverse Events
time frame: 33 weeks
Tolerability- Percentage of participants who fail to complete the study
time frame: 33 weeks
Percentage of participants who fail to complete the study due to adverse events
time frame: 33 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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

Additional Information

Official title A 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
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Teva Pharmaceutical Industries.