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Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

NCT01129661 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2011-01-24

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.

Conditions

  • Healthy

Interventions

BIOLOGICAL

CSL112 (reconstituted HDL)

Single escalating intravenous doses of CSL112

BIOLOGICAL

normal saline (0.9%)

Single intravenous dose of normal saline (0.9%)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-12-31
Completion
2011-01-31

Countries

  • Australia

Study Locations

More Related Trials

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 NCT01129661 on ClinicalTrials.gov