Date: 2011-01-07
Type of information:
phase: 1
Announcement: results
Company: 4SC (Germany)
Product: 4SC-203
Action mechanism: multi-targetkinase inhibitor
Disease:
Therapeutic area: Cancer Oncology
Country:
Trial
details: 4SC AG announced successful completion of its first-in- man phase I study in healthy volunteers with the multi-target kinase inhibitor 4SC-203. In this randomised, double-blind, placebo-controlled, Phase I dose escalation study the safety, tolerability, and pharmacokinetics of 4SC-203 was assessed in 60 healthy, male volunteers aged 20 to 46 years.
Cohorts of eight subjects each, radomised in a 6:2 ratio (active:placebo), received ascending single intravenous doses of the compound. The dose range comprised 0.041 to 2.5 mg/kg, which corresponds to a total dose of 2.5 to 150 mg for an individual of 60 kg body weight.
4SC-203 proved to be safe and was well tolerated by all subjects. Only 33% of volunteers experienced adverse events, which were all graded of mild intensity with the exception of three events which were moderate. No dose-dependent increase in the number of Treatment-Emergent Adverse Events and no Serious Adverse Event were observed. No changes in physical and laboratory parameters were recorded and no target organ toxicity occurred.
Pharmacokinetics of 4SC-203 in the investigated concentration range of the applied doses displayed the expected dose-dependent increase, providing an excellent basis for the further clinical development of 4SC-203.
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