Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

An Adaptive, Phase I, Single-Centre, Randomised, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics, of Intravenous CSL112 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01129661

Enrollment

Registered

2010-05-25

Start date

2010-06-30

Completion date

2011-01-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

BIOLOGICALCSL112 (reconstituted HDL)

Single escalating intravenous doses of CSL112

BIOLOGICALnormal saline (0.9%)

Single intravenous dose of normal saline (0.9%)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 54 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as measured by the frequency of drug-related clinical adverse events.	Up to 14 days after infusion of CSL112
Safety and tolerability as measured by liver function tests.	Up to 14 days after infusion of CSL112

Secondary

Measure	Time frame	Description
Pharmacokinetics of lipoprotein.	Up to 10 days after infusion of CSL112	Plasma levels of lipoprotein.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026