Cytokinetics Announces Initiation of Phase 1 Study of Aficamten in Healthy Japanese Participants [Yahoo! Finance]
Cytokinetics, Incorporated (CYTK)
Last cytokinetics, incorporated earnings: 3/3 04:00 pm
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Source: Yahoo! Finance
have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. “We are conducting this Phase 1 bridging study to characterize the pharmacokinetics of aficamten in healthy Japanese adults and to gather evidence that we believe will be required for potential approval in Japan,” said Fady I. Malik, M.D., Ph.D., Cytokinetics' Executive Vice President of Research & Development. “In parallel, we are continuing to execute on our later-stage global clinical development program for aficamten alongside preparing regulatory submissions in the U.S. and Europe which we expect to submit this year.” Phase 1 Clinical Trial Design The primary objective of this Phase 1 double-blind, randomized, placebo controlled study is to evaluate the pharmacokinetics of aficamten following administration of single ascending doses and multiple doses in 70 healthy Japanese and Caucasian participants. The secondary objectiv
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- 9/17/24 - Form 4
- 9/17/24 - Form 144
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