drugset / Trial / NCT01281774
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.
Timeline
- Start
- 2011-01
- Primary completion
- 2011-06
- Completion
- 2011-06
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.
- Easton 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CSL112 | Protein / enzyme biologic | 3.4 g | Intravenous |
| Subject | CSL112 | Protein / enzyme biologic | 6.8 g | Intravenous |
Indications
No indication recorded.