Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

CSL Limited

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: normal saline (0.9%); Biological: CSL112 (reconstituted HDL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129661

CSLCT-HDL-09-63

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

normal saline (0.9%)

Placebo Comparator group

Treatment:

Biological: normal saline (0.9%)

CSL112

Experimental group

Treatment:

Biological: CSL112 (reconstituted HDL)