3 ms·
"to evaluate the safety, tolerability, and preliminary efficacy of EBT-101" The primary question is "will anyone die or have extreme negative side effects". Th
by hiddencost 3y ago
"to evaluate the safety, tolerability, and preliminary efficacy of EBT-101"
The primary question is "will anyone die or have extreme negative side effects". They run the study small in this phase because it might kill or seriously harm the entire study population.
Once they know that nothing extremely bad happened, they'll try on bigger populations.
- whimsicalism 3y agoMy understanding was this is actually a combined phase 1/2 trial not just phase 1
- mlyle 3y agoThat's (phase 2) the preliminary efficacy bit mentioned. But it's not really looking for a great, high quality signal: just some evidence that some indicators move in patients and not necessarily even statistical significance before moving to a phase 3 trial designed to measure benefit. They expect a big enough effect on the virus to be able to measure it in this tiny population.