Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129661
• Other study ID #: CSLCT-HDL-09-63
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2010
• Last updated: January 20, 2011
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: CSL Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 54 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• CSL112 (reconstituted HDL)
Single escalating intravenous doses of CSL112
• normal saline (0.9%)
Single intravenous dose of normal saline (0.9%)

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
CSL Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as measured by the frequency of drug-related clinical adverse events.		Up to 14 days after infusion of CSL112	Yes
Primary	Safety and tolerability as measured by liver function tests.		Up to 14 days after infusion of CSL112	Yes
Secondary	Pharmacokinetics of lipoprotein.	Plasma levels of lipoprotein.	Up to 10 days after infusion of CSL112	No