A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

Healthy Clinical Trial

Official title:

An Adaptive, Phase I, Randomised, Placebo-controlled, Sponsor-unblinded, Multiple 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: NCT01281774
• Other study ID #: CSLCT-HDL-10-68
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2011
• Last updated: March 6, 2012
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: March 2012
• 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, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• CSL112
reconstituted high density lipoprotein
• Placebo
Normal saline (0.9%)

Locations

Country	Name	City	State
Australia	Q-Pharm	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
CSL Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of drug-related adverse events		Up to 6 days after each infusion	Yes
Primary	The frequency of redness and swelling at the infusion site		up to 24 hours after each infusion	Yes
Primary	Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)		up to 6 days after each infusion	Yes
Secondary	Pharmacokinetic profile of apoA-I after multiple intravenous infusions		up to 7 days after each infusion	No