Status:
COMPLETED
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants
Lead Sponsor:
Takeda
Conditions:
Autoimmune Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to characterize the pharmacokinetic and safety and tolerability profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC) administration at esca...
Detailed Description
The drug being tested in this study is TAK-079. TAK-079 is being tested to find a safe and well-tolerated dose and to assess how TAK-079 is processed by the body. This study will look at pharmacokinet...
Eligibility Criteria
Inclusion
- Is a healthy male or female with no child bearing potential who is 18 to 55 years of age inclusive.
- The subject weighs at least 70 kilogram (kg) for cohort 1 and subsequent cohorts 50 kg (110.2 lb) and less than 100 kg (220.5 lb) and has a body mass index (BMI) range of 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at Screening Visit 1.
- A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after last dose of study medication.
Exclusion
- Has received any investigational compound within the last 3 months or 5\*T1/2 of the investigational compound,whichever is longer, prior to the day of study medication (Day 1).
- Has received any live vaccinations, within the last 3 months prior to Screening or is expected to receive any vaccinations during the study or for 1 month after the Day 78 Study Exit visit.
- Has received any other biologic medical products at any time in the past.
- Has a positive drug or alcohol screening result, or a history of drug or alcohol abuse.
- Has a positive test result for hepatitis or human immunodeficiency virus antibody.
- Has any signs of an acute infection or history of frequent or chronic infection, or herpes zoster.
- Has active or latent tuberculosis (TB)
- Considered unfit for the study by the Principal Investigator.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02219256
Start Date
August 1 2014
End Date
April 1 2016
Last Update
May 3 2017
Active Locations (2)
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1
London, London, United Kingdom
2
Headington, Oxford, United Kingdom