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Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

NCT01486823 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-12-11

No results posted yet for this study

Summary

This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.

Conditions

  • Healthy

Interventions

DRUG

MLDL1278A

Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.

DRUG

MLDL1278A

Single subcutaneous dose of 360 mg MLDL1278A.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • BioInvent International AB

    lead INDUSTRY

Principal Investigators

  • Darren Wilbraham, MD · Quintiles, Inc.

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United Kingdom

Study Locations

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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 NCT01486823 on ClinicalTrials.gov