We all know that a lot of bozos are trying to diminish the successes we are seeing with our current ph 1 trial. Just a reminder to all of the scope of this trial.
Objectives of the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation Phase 1 study of oral Brilacidin include:
• To visualize, using gamma scintigraphy:
o the site of release of enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon.
o the disintegration and dispersion of Brilacidin delayed release tablets in vivo.
• To evaluate the safety and tolerability of Brilacidin administered by delayed release tablet as single escalating doses.
• To assess systemic exposure/pharmacokinetics of Brilacidin following administration of delayed release tablets.
Nowhere does it even hint at doing a microbiome study. End of discussion and glad the post was removed. Should be a very exciting next few weeks. GLTA!
Objectives of the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation Phase 1 study of oral Brilacidin include:
• To visualize, using gamma scintigraphy:
o the site of release of enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon.
o the disintegration and dispersion of Brilacidin delayed release tablets in vivo.
• To evaluate the safety and tolerability of Brilacidin administered by delayed release tablet as single escalating doses.
• To assess systemic exposure/pharmacokinetics of Brilacidin following administration of delayed release tablets.
Nowhere does it even hint at doing a microbiome study. End of discussion and glad the post was removed. Should be a very exciting next few weeks. GLTA!
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