A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT01281774
• Lead Sponsor: CSL Limited

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-21
• Study First Posted: 2011-01-24
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy males and females aged 18 years to less than 55 years
• Body weight 50kg or greater
• Body mass index (BMI) between 18 and 42.0 kg/m2

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The frequency of drug-related adverse events	Up to 6 days after each infusion
The frequency of redness and swelling at the infusion site	up to 24 hours after each infusion
Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)	up to 6 days after each infusion

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of apoA-I after multiple intravenous infusions	up to 7 days after each infusion

Trial Locations

Locations (1)

Q-Pharm; 🇦🇺 Brisbane, Queensland, Australia