Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: 33 weeks
measure: Time to maximum observed plasma drug concentration (tmax)
timeFrame: 33 weeks
measure: AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)
timeFrame: 33 weeks
measure: AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)
timeFrame: 33 weeks
measure: AUC from time 0 extrapolated to infinity (AUC0-∞)
timeFrame: 33 weeks
measure: Percentage extrapolated AUC (%AUCext)
timeFrame: 33 weeks
measure: Apparent serum terminal elimination rate constant (λz)
timeFrame: 33 weeks
measure: Apparent total body clearance (CL/F)
timeFrame: 33 weeks
measure: Apparent volume of distribution during the terminal phase (Vz/F)
timeFrame: 33 weeks
measure: Apparent serum terminal elimination half-life (t½)
timeFrame: 33 weeks
Secondary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: 33 weeks
measure: Tolerability- Percentage of participants who fail to complete the study
timeFrame: 33 weeks
measure: Percentage of participants who fail to complete the study due to adverse events
timeFrame: 33 Weeks
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Teva Investigational Site 13529
state: California
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: