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news.Chelsea Therapeutics International, a biopharmaceutical development company, has started dosing volunteers in the single ascending dose study of its Phase I clinical program for CH-4051, the second drug candidate from its portfolio of orally available, non-metabolized antifolates engineered to provide potent anti-inflammatory activity without the liver and kidney toxicities or tolerability related side effects associated with chronic methotrexate therapy.
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The randomized, double-blind placebo controlled study will evaluate the safety, tolerability and pharmacokinetics of ascending doses of CH-4051 in healthy male volunteers and is being conducted at Kendle International’s clinical pharmacology unit in the Netherlands.
The single ascending dose (SAD) study is expected to include four cohorts of six healthy subjects with a 5:1 randomization. Dose escalation for each cohort will be based on the safety and tolerability data from the previous cohort.
Following the SAD evaluation, the study will progress to a multiple ascending dose (MAD) evaluation and seek to determine a maximum tolerated dose (MTD). Though ultimately dependant on MTD, the MAD study is currently expected to evaluate four cohorts of eight subjects in a 6:2 randomization. Each cohort will be treated for 14 days and dose escalation will be based on the safety and tolerability data from the previous cohort.
Simon Pedder, president and CEO of Chelsea, said: “Based on our preclinical results to date, we believe CH-4051 could expand on the promise demonstrated by our lead antifolate, CH-1504, by broadening our target profile to include a potentially more efficacious treatment alternative to methotrexate while maintaining a highly tolerable safety profile. Together, both compounds represent a development opportunity in this significant market.”