NCT02673567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 31, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2017

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

January 26, 2016

Last Update Submit

December 8, 2021

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (10)

  • 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

  • Percentage extrapolated AUC (%AUCext)

    33 weeks

  • Apparent serum terminal elimination rate constant (λz)

    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 Outcomes (3)

  • 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

Study Arms (4)

TEV-48125 - 1

EXPERIMENTAL

Dose Regimen 1

Drug: TEV-48125 - 1

TEV-48125 - 2

EXPERIMENTAL

Dose Regimen 2

Drug: TEV-48125 - 2

TEV-48125 - 3

EXPERIMENTAL

Dose Regimen 3

Drug: TEV-48125 - 3

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

TEV-48125 - 1DRUG

Subcutaneous administration Dose Regimen 1

Also known as: monoclonal antibody
TEV-48125 - 1
TEV-48125 - 2DRUG

Subcutaneous administration Dose Regimen 2

Also known as: monoclonal antibody
TEV-48125 - 2
TEV-48125 - 3DRUG

Subcutaneous administration Dose Regimen 3

Also known as: monoclonal antibody
TEV-48125 - 3
PlaceboDRUG

Matching Placebo

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teva Investigational Site 13529

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

Antibodies, Monoclonal

Intervention Hierarchy (Ancestors)

AntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Teva Medical Expert, MD

    Teva Branded Pharmaceutical Products R&D, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 4, 2016

Study Start

March 31, 2016

Primary Completion

December 16, 2016

Study Completion

February 10, 2017

Last Updated

December 13, 2021

Record last verified: 2021-12

Locations

US(1)