Cytokinetics Inc. (CYTK) announced positive data from Part B of Phase I, first-time-in-humans, randomized, double-blind, placebo-controlled, clinical trial of CK-2017357 in healthy volunteers.
Part B of the trial was designed to assess the pharmacodynamic effects of CK-2017357 on skeletal muscle function after single oral doses of 250, 500, and 1000 mg, and to assess the relationship of the effects observed to the associated plasma concentrations of CK-2017357. The company announced that CK-2017357 produced concentration-dependent, statistically significant increases versus placebo in the force developed by the tibialis anterior, the muscle evaluated in this trial, and that the doses administered were well tolerated by the healthy volunteers that participated.
Part A of the trial was designed to assess the safety, tolerability, and pharmacokinetic profile of increasing single doses of this drug candidate in healthy volunteers and to determine its maximum-tolerated dose and plasma concentration. The company announced that, to date, single doses up to 2000 mg have been administered without causing intolerable adverse events; accordingly, the maximum-tolerated dose has not yet been determined, and Cytokinetics continues to escalate the dose in this ongoing trial.
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