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A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants

NCT02219256 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-05-03

Study results available
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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 escalating dose levels in healthy participants.

Conditions

Interventions

DRUG

TAK-079

TAK-079 solution

DRUG

Placebo to TAK-079

Placebo to TAK-079 solution

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02219256 on ClinicalTrials.gov