How Does Voclosporin Work?
Multiple Ascending Dose Study Summary
| Trial Design: | The MAD trial was conducted in 43 healthy subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of trans-voclosporin in healthy subjects. |
| Dosing Groups: | Dose group 1- 0.25 mg/kg |
| Conclusion: | At anticipated therapeutic doses for psoriasis treatment (0.3 mg/kg BID), subjects experienced no clinically significant impact on renal function as measured by serum creatinine or 24-hour creatinine clearance. All safety endpoints of the study were achieved. |
Other currently marketed medications belonging to the same therapeutic class of drugs (i.e. calcineurin inhibitors) exhibit clinically significant deleterious effects on kidney function at therapeutic doses. The absence of these renal effects with voclosporin, therefore, is clinically significant.