Chelsea Therapeutics International has completed a Phase Ib trial of its leading drug candidate, CH-1504, an orally available, metabolically inert, anti-inflammatory and antitumor agent for the treatment of rheumatoid arthritis, psoriasis, inflammatory bowel disease and certain cancers. Data from this multiple-ascending-dose study demonstrates that CH-1504 is safe and well-tolerated at all evaluated doses, with no clinically significant abnormalities observed.
The study objectives were to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending oral doses of CH-1504 in healthy male volunteers. In the study, 24 volunteers in three cohorts of eight subjects received either placebo or CH-1504 in repeat doses ranging from 7.5 mg to 15 mg once-daily for seven consecutive days.
Pharmacokinetic data from this trial suggest that CH-1504 is suitable for daily administration at dosage levels that are predicted to be therapeutically effective. Preliminary analysis of the pharmacokinetic data from this study suggest that CH-1504 kinetics are predictable and stable over a seven-day dosing period and that the drug will be suitable for daily administration.