Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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normal saline (0.9%)

Group Type PLACEBO_COMPARATOR

normal saline (0.9%)

Intervention Type BIOLOGICAL

Single intravenous dose of normal saline (0.9%)

CSL112

Group Type EXPERIMENTAL

CSL112 (reconstituted HDL)

Intervention Type BIOLOGICAL

Single escalating intravenous doses of CSL112

Interventions

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CSL112 (reconstituted HDL)

Single escalating intravenous doses of CSL112

Intervention Type BIOLOGICAL

normal saline (0.9%)

Single intravenous dose of normal saline (0.9%)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females aged 18 years to less than 55 years
* Body weigh 45 kg or greater

Exclusion Criteria

* Evidence of a clinically significant medical condition, disorder or disease
* Evidence of clinically relevant abnormal laboratory test result
* Evidence of history of alcohol or substance abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes