Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

Phase 1 Completed 57 enrolled CSL Limited

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2010-06
Primary completion: 2010-12
Completion: 2011-01

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CSL112	Protein / enzyme biologic	—	Intravenous

Indications

No indication recorded.