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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01281774




Registration number
NCT01281774
Ethics application status
Date submitted
21/01/2011
Date registered
24/01/2011
Date last updated
7/03/2012

Titles & IDs
Public title
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
CSLCT-HDL-10-68
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
Treatment: Other - Placebo

Experimental: CSL112 - Multiple ascending intravenous doses of CSL112

Placebo comparator: Placebo - Multiple intravenous infusions of placebo


Treatment: Other: CSL112
reconstituted high density lipoprotein

Treatment: Other: Placebo
Normal saline (0.9%)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The frequency of drug-related adverse events
Timepoint [1] 0 0
Up to 6 days after each infusion
Primary outcome [2] 0 0
The frequency of redness and swelling at the infusion site
Timepoint [2] 0 0
up to 24 hours after each infusion
Primary outcome [3] 0 0
Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Timepoint [3] 0 0
up to 6 days after each infusion
Secondary outcome [1] 0 0
Pharmacokinetic profile of apoA-I after multiple intravenous infusions
Timepoint [1] 0 0
up to 7 days after each infusion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 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 hepatobiliary disease
* Any clinically relevant abnormal laboratory test result
* Evidence or 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 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
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

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, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.
Trial website
https://clinicaltrials.gov/study/NCT01281774
Trial related presentations / publications
Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
Easton R, Gille A, D'Andrea D, Davis R, Wright SD, Shear C. A multiple ascending dose study of CSL112, an infused formulation of ApoA-I. J Clin Pharmacol. 2014 Mar;54(3):301-10. doi: 10.1002/jcph.194. Epub 2013 Oct 22.
Public notes

Contacts
Principal investigator
Name 0 0
Senior Director, Cardiovascular
Address 0 0
CSL Limited
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/study/NCT01281774