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CHELSEA GETS POSITIVE RESULTS FROM PHASE I CH-4051 TRIAL.

Publication: Biotech Business
Publication Date: 01-JUN-09
Format: Online
Delivery: Immediate Online Access

Article Excerpt
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP), Charlotte, N.C. has announced positive findings from its Phase I trial of CH-4051, the L-isomer of CH-1504 and second drug candidate from its portfolio of orally bioavailable, non-metabolized antifolates. Data from this single and multiple ascending dose study demonstrated that CH-4051 is safe and well tolerated up to a maximally tolerated dose of 7.5mg.

This randomized, double-blind, placebo-controlled study was conducted at Kendle International's Clinical Pharmacology Unit in the Netherlands. The primary objective of the study was to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of CH-4051 in healthy male volunteers and to determine the maximally tolerated dose (MTD)....

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