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Cara Therapeutics (CARA) Announces Data From Quantitative Phase 1 Trial Measuring Respiratory Safety of I.V. CR845

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Additional Relevant Details The primary safety endpoints were: a > 10 mmHg sustained ( > 30 seconds duration) increase in ETCO2 above baseline or to > 50 mmHg, and a sustained reduction in SpO2 to < 92 percent.Mean ETC02 pre-dosing ranged from 36.1 ± 3.9 to 37.8 ± 2.9 mmHg across treatment groups. At one hour post-administration, ETC02 values for placebo, CR845 1.0 ug/kg and CR845 5.0 ug/kg treatment groups were numerically and statistically equivalent at 38.1 ± 2.8, 38.1 ± 3.1, and 38.3 ± 2.9 mmHg, respectively. Pre-treatment levels of SpO2 ranged from 98.3 percent ± 1.2 to 98.9 percent ± 1.0 and were measured at 97.8 percent ± 1.2, 98.2 percent ± 1.5 and 97.9 percent ± 1.0 for placebo, CR845 1.0 ug/kg and CR845 5.0 ug/kg treatment groups respectively, at one hour post-treatment. There were no statistically significant differences in any respiratory measures between groups throughout the four-hour observation period and no individual patient met the threshold for a respiratory safety event.All reported treatment-emergent adverse events were previously reported with CR845 administration and were mild, resolving without intervention.
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Catalyst Date
Occurred on:
Apr 24, 2017
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Related Keywords Phase 1 Data, Cr845