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Daclizumab Japanese PK Study

NCT01929746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-05-02

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).

Conditions

  • Healthy

Interventions

BIOLOGICAL

BIIB019 subcutaneous injection

participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT01929746 on ClinicalTrials.gov