Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
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
Objective
- To assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers.
- To measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.
Sponsor
CSL Limited
Timeline
| Timeline | |
| Start Date | June 2010 |
| End Date | December 2010 |
| Status | Completed |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | |
| Allocation | Randomized |
| Endpoint | Safety study |
| Interventional Model | Parallel assignment |
| Masking | Double blind (subject, caregiver, investigator, outcomes assessor) |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Healthy |
| Intervention | CSL112 (reconstituted HDL) single escalating intravenous doses |
| Study Arms | Experimental:CSL112 (reconstituted HDL) Placebo comparator:normal saline (0.9%) |
| Population Size | 57 |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01129661.
Eligibility Criteria
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
Outcomes
Primary Outcomes
- Safety and tolerability as measured by the frequency and intensity of clinical adverse events
- Time Frame: Up to 14 days after infusion of CSL112
- Designated as safety issue: Yes
- Safety and tolerability as measured by clinical laboratory tests and assessments
- Time Frame: Up to 14 days after infusion of CSL112
- Designated as safety issue: Yes
- Pharmacokinetics of CSL112
- Time Frame: Up to 10 days after infusion of CSL112
- Designated as safety issue: No
Secondary Outcomes
- Pharmacokinetic and pharmacodynamic measures of lipid, lipoprotein and related exploratory biomarkers
- Time Frame: Up to 10 days after infusion of CSL112
- Designated as safety issue: No
Publications
Results
Conclusion
References
© 2026 MyEClinic – IFTM Institut für Telematik in der Medizin GmbH