A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

CSL Limited

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: CSL112; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01281774

CSLCT-HDL-10-68

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

CSL112

Experimental group

Description:

Multiple ascending intravenous doses of CSL112

Treatment:

Biological: CSL112

Placebo

Placebo Comparator group

Description:

Multiple intravenous infusions of placebo

Treatment:

Biological: Placebo