NCT01129661

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2010

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 19, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

May 19, 2010

Last Update Submit

January 20, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability as measured by the frequency of drug-related clinical adverse events.

    Up to 14 days after infusion of CSL112

  • Safety and tolerability as measured by liver function tests.

    Up to 14 days after infusion of CSL112

Secondary Outcomes (1)

  • Pharmacokinetics of lipoprotein.

    Up to 10 days after infusion of CSL112

Study Arms (2)

normal saline (0.9%)

PLACEBO COMPARATOR
Biological: normal saline (0.9%)

CSL112

EXPERIMENTAL
Biological: CSL112 (reconstituted HDL)

Interventions

CSL112 (reconstituted HDL)BIOLOGICAL

Single escalating intravenous doses of CSL112

CSL112
normal saline (0.9%)BIOLOGICAL

Single intravenous dose of normal saline (0.9%)

normal saline (0.9%)

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females aged 18 years to less than 55 years
  • Body weigh 45 kg or greater

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

  • 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: 33217027DERIVED

MeSH Terms

Interventions

CSL112Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 25, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

AU(1)