Healthy
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.
Interventions
BIOLOGICALCSL112
reconstituted high density lipoprotein
BIOLOGICALPlacebo
Normal saline (0.9%)
Sponsors
CSL Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile of apoA-I after multiple intravenous infusions | up to 7 days after each infusion |
Countries
Australia
Outcome results
None listed