Biotech

Cytokinetics (NASDAQ:CYTK) has announced the first subject has been dosed in a Phase 1 randomized, double-blind, placebo-controlled and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 594 in healthy patients. As quoted in the press release: AMG 594 is a cardiac troponin activator, discovered under a joint research program …

Cytokinetics (NASDAQ:CYTK) has announced the first subject has been dosed in a Phase 1 randomized, double-blind, placebo-controlled and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 594 in healthy patients.

As quoted in the press release:

AMG 594 is a cardiac troponin activator, discovered under a joint research program conducted between Amgen and Cytokinetics. The study is being conducted by Amgen in collaboration with Cytokinetics.

“The initiation of this Phase 1 study of AMG 594 further reflects the productivity of our collaboration with our partner, Amgen,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “We are pleased that we are together advancing into the clinic another cardiac sarcomere activator, the first one selective for cardiac troponin, as it may provide differentiated effects as a potential treatment for various forms of heart failure and other conditions of reduced cardiac contractility.”

Phase 1 Clinical Trial Design

The primary objective of this Phase 1 randomized, double-blind, placebo-controlled, single and multiple ascending dose trial is to assess the safety and tolerability of AMG 594 when administered orally as single or multiple doses to healthy subjects. The study design includes several single ascending dose cohorts and three multiple ascending dose cohorts, with eight healthy subjects per cohort. Additional objectives include describing the pharmacokinetics of AMG 594 and its pharmacodynamic effects as measured by echocardiography.

Click here to read the full press release.

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