Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: normal saline (0.9%); Biological: CSL112 (reconstituted HDL)

• Registration Number: NCT01129661
• Lead Sponsor: CSL Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-21
• Study First Posted: 2010-05-25
• Study Start: 2010-06
• Primary Completion: 2010-12
• Status Verified: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline (0.9%)	normal saline (0.9%)	-
CSL112	CSL112 (reconstituted HDL)	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by the frequency of drug-related clinical adverse events.	Up to 14 days after infusion of CSL112
Safety and tolerability as measured by liver function tests.	Up to 14 days after infusion of CSL112

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of lipoprotein.	Up to 10 days after infusion of CSL112	Plasma levels of lipoprotein.

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia