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Re: mcbio post# 84244

Tuesday, 09/29/2009 4:10:11 PM

Tuesday, September 29, 2009 4:10:11 PM

Post# of 257257

I am just curious if it's normal to see adverse events of any kind in a Phase 1a trial for an HCV PI in healthy patients

You don't want to see clinically significant lab abnormalities or that the drug has a clinically significant effect on vital signs, QTc or ECG parameters. You can see AE in a phase 1a trial like in the case of ANA598, where 3 of 24 subjects dosed with ANA598 discontinued therapy due to grade 2 rash in the a healthy volunteer study (it was a 14 day study though).

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