Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01129661




Registration number
NCT01129661
Ethics application status
Date submitted
19/05/2010
Date registered
25/05/2010
Date last updated
24/01/2011

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
CSLCT-HDL-09-63
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CSL112 (reconstituted HDL)
Other interventions - normal saline (0.9%)

Placebo Comparator: normal saline (0.9%) -

Experimental: CSL112 -


Other interventions: CSL112 (reconstituted HDL)
Single escalating intravenous doses of CSL112

Other interventions: normal saline (0.9%)
Single intravenous dose of normal saline (0.9%)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability as measured by the frequency of drug-related clinical adverse events.
Timepoint [1] 0 0
Up to 14 days after infusion of CSL112
Primary outcome [2] 0 0
Safety and tolerability as measured by liver function tests.
Timepoint [2] 0 0
Up to 14 days after infusion of CSL112
Secondary outcome [1] 0 0
Pharmacokinetics of lipoprotein.
Timepoint [1] 0 0
Up to 10 days after infusion of CSL112

Eligibility
Key inclusion criteria
- Healthy males and females aged 18 years to less than 55 years

- Body weigh 45 kg or greater
Minimum age
18 Years
Maximum age
54 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01129661
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01129661