- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01129661
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers
January 20, 2011 updated by: CSL Limited
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- CMAX
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 54 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males and females aged 18 years to less than 55 years
- Body weigh 45 kg or greater
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: normal saline (0.9%)
|
Single intravenous dose of normal saline (0.9%)
|
EXPERIMENTAL: CSL112
|
Single escalating intravenous doses of CSL112
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability as measured by the frequency of drug-related clinical adverse events.
Time Frame: Up to 14 days after infusion of CSL112
|
Up to 14 days after infusion of CSL112
|
Safety and tolerability as measured by liver function tests.
Time Frame: Up to 14 days after infusion of CSL112
|
Up to 14 days after infusion of CSL112
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of lipoprotein.
Time Frame: Up to 10 days after infusion of CSL112
|
Plasma levels of lipoprotein.
|
Up to 10 days after infusion of CSL112
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
May 19, 2010
First Submitted That Met QC Criteria
May 21, 2010
First Posted (ESTIMATE)
May 25, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 20, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- CSLCT-HDL-09-63
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on normal saline (0.9%)
-
Ann & Robert H Lurie Children's Hospital of ChicagoWithdrawn
-
University of HaifaWestern Galilee Hospital-NahariyaRecruiting
-
Virginia Commonwealth UniversityUnited States Department of DefenseWithdrawn
-
Vanderbilt University Medical CenterActive, not recruitingPostural Tachycardia SyndromeUnited States
-
Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Center for Research...Active, not recruitingOrthostatic Intolerance | Postural Tachycardia Syndrome | Orthostatic TachycardiaUnited States
-
Taipei Veterans General Hospital, TaiwanUnknown
-
Lawson Health Research InstituteCompleted
-
Tehran University of Medical SciencesTehran Heart CenterCompletedContrast Induced NephropathyIran, Islamic Republic of
-
University Hospital Inselspital, BerneCompletedCardiovascular Diseases | Valvular Heart DiseaseSwitzerland
-
Yasser S Mostafa, MDFayoum University HospitalRecruiting