A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Objective

To measure the biomarkers of cholesterol movement following a single and multiple infusions of CSL-112 in healthy subjects.

Methods

36 healthy subjects were divided into 3 dosing groups: 4 once-weekly infusions of 3.4 g, 4 once-weekly infusions of 6.8 g, and 8 twice-weekly infusions of 3.4 g and biomarkers of cholesterol movement - cholesterol efflux capacity, serum preBeta1-HDL and HDL were measured.

Results

• Infusions of CSL-112 caused immediate and profound elevation in all the biomarkers.

• Serum preBeta1-HDL elevation was up to 20-fold.

• Serum preBeta1-HDL and cholesterol efflux capacity peaked after infusion and returned to baseline at 24 hour while there was a 72 hour sustained response for serum HDL following its peak at 24-48 hours after infusion.
• Multiple infusions of CSL112 causes a greater efflux of cholesterol from tissues to HDL when compared with a single infusion.
• No observed changes in the baseline of other lipoproteins.

Conclusion

Single and multiple infusions of CSL-112 in healthy subjects rapidly initiates the reverse cholesterol transport, and this is beneficial in rapidly lowering the risk of recurrent cardiovascular events following acute coronary syndromes.