A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
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
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jan 2011
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 7, 2012
March 1, 2012
5 months
January 21, 2011
March 6, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
The frequency of drug-related adverse events
Up to 6 days after each infusion
The frequency of redness and swelling at the infusion site
up to 24 hours after each infusion
Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
up to 6 days after each infusion
Secondary Outcomes (1)
Pharmacokinetic profile of apoA-I after multiple intravenous infusions
up to 7 days after each infusion
Study Arms (2)
CSL112
EXPERIMENTALMultiple ascending intravenous doses of CSL112
Placebo
PLACEBO COMPARATORMultiple intravenous infusions of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Limitedlead
Study Sites (1)
Q-Pharm
Brisbane, Queensland, 4006, Australia
Related Publications (2)
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.
PMID: 33217027DERIVEDEaston 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.
PMID: 24122814DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Senior Director, Cardiovascular
CSL Limited
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2011
First Posted
January 24, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 7, 2012
Record last verified: 2012-03