Clinical Trials
ImmuneSensor is evaluating IMSB301 in a Phase 1 randomized, placebo-controlled, double-blinded clinical trial which is being conducted in healthy volunteers in Australia.
The primary endpoint of the clinical study is safety and tolerability, along with pharmacokinetics (PK) and engagement (inhibition) of the cGAS target. The study will enroll cohorts of eight subjects each (two subjects receive placebo and six subjects receive IMSB301 at each dose) with up to five single ascending dose (SAD) levels, and subsequently up to three multiple ascending dose (MAD) levels. PK will be assessed in both SAD and MAD arms and cGAS target engagement will be evaluated in the MAD arm using an ex vivo whole blood DNA stimulation assay. The first dose cohort of the SAD arm has been completed with the observed exposure levels and PK as predicted from nonclinical IND-enabling studies.
For more information on the ongoing trial, please visit the ISRCTN registry: https://www.isrctn.com/ISRCTN90049550