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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - CSL112 (reconstituted HDL)
Treatment: Other - normal saline (0.9%)

Placebo comparator: normal saline (0.9%) -

Experimental: CSL112 -


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

Treatment: Other: normal saline (0.9%)
Single intravenous dose of normal saline (0.9%)
Intervention code [1] 0 0
Treatment: Other
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01129661