HealthyPhase 1NCT01129661
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers
A Phase 1 study testing CSL112 (reconstituted HDL) and normal saline (0.9%) in people with Healthy, run by CSL Limited at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CSL112 (reconstituted HDL) and normal saline (0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 18 years to less than 55 years
- Body weigh 45 kg or greater
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Healthy
- Being tested
- CSL112 (reconstituted HDL), normal saline (0.9%)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL112 (reconstituted HDL)Biological
Single escalating intravenous doses of CSL112
normal saline (0.9%)Biological
Single intravenous dose of normal saline (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| normal saline (0.9%) | Placebo comparator | Not described Receives: Biological: normal saline (0.9%) |
| CSL112 | Experimental | Not described Receives: Biological: CSL112 (reconstituted HDL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as measured by the frequency of drug-related clinical adverse events.
Measured: Up to 14 days after infusion of CSL112
Safety and tolerability as measured by liver function tests.
Measured: Up to 14 days after infusion of CSL112
Secondary outcomes (1)
Pharmacokinetics of lipoprotein.
Plasma levels of lipoprotein.
Measured: Up to 10 days after infusion of CSL112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129661
- Sponsor's protocol ID
- CSLCT-HDL-09-63
- Status last verified
- Jan 2011
- First submitted
- 19 May 2010
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33217027
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01129661
- Acronym / sponsor ID
- CSLCT-HDL-09-63
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- CSL LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline (0.9%) | Placebo comparator | Biological: normal saline (0.9%) |
| CSL112 | Experimental | Biological: CSL112 (reconstituted HDL) |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females aged 18 years to less than 55 years
- Body weigh 45 kg or greater
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL112 (reconstituted HDL)Single escalating intravenous doses of CSL112 | Biological | CSL112 |
| normal saline (0.9%)Single intravenous dose of normal saline (0.9%) | Biological | normal saline (0.9%) |
Primary outcome
Safety and tolerability as measured by the frequency of drug-related clinical adverse events.
Time frame: 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
1 secondary outcome
Pharmacokinetics of lipoprotein.
Time frame: Up to 10 days after infusion of CSL112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
- Derived from this study: PubMed 33217027Zheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CSL112 (reconstituted HDL) and normal saline (0.9%) in people with Healthy, run by CSL Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as measured by the frequency of drug-related clinical adverse events. (time frame: Up to 14 days after infusion of CSL112). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01129661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.