No. For phase 1, it's generally sufficient to show that few or no people had life-threatening adverse effects, that none of the life threatening effects were plausibly related to the drug, and there were no meaningful hiccups in CNS, pulmonary, or cardiac function.
In this case, they went for a placebo set-up because they were also trying to grab a little data to show whether 25 mg was significantly distinct from 10mg. The comparison to placebo was not needed, but is winning them a little extra publicity.
In this case, they went for a placebo set-up because they were also trying to grab a little data to show whether 25 mg was significantly distinct from 10mg. The comparison to placebo was not needed, but is winning them a little extra publicity.