A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: CSL112Biological: Placebo
- 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
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
- Arm && Interventions
Group Intervention Description CSL112 CSL112 Multiple ascending intravenous doses of CSL112 Placebo Placebo Multiple intravenous infusions of placebo
- 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