Phase 1 done results in Q1
<10 ppm).="" cardiols="" phase="" i="" double-blind,="" placebo-controlled,="" randomized="" study="" was="" designed="" to="" assess="" safety,="" tolerability,="" and="" pharmacokinetics="" of="" single,="" followed="" by="" multiple="" day="" ascending="" doses="" of="" cardiolrx="" administered="" orally="" to="" 52="" healthy="" adult="" subjects,="" both="" in="" the="" fasting="" and="" fed="" states.="" the="" therapy="" was="" shown="" to="" be="" generally="" well="" tolerated="" with="" no="" serious="" adverse="" events="" reported="" in="" the="" study="" and="" 51="" subjects="" completed="" all="" requirements="" of="" the="" study="" protocol.="" by="" measuring="" standard="" safety="" parameters="" and="" the="" pharmacokinetics="" of="" cardiolrx,="" including="" the="" degree="" of="" drug="" absorption="" and="" resulting="" blood="" levels="" at="" escalating="" doses,="" the="" phase="" 1="" study="" will="" provide="" important="" information="" to="" optimize="" dosing="" levels.="" the="" results="" of="" the="" study="" are="" expected="" in="" early="" q1,="" 2021,="" and="" will="" form="" an="" integral="" part="" of="" the="" companys="" planned="" ind="" application="" with="" the="" fda="" for="" an="" international="" phase="" ii="" clinical="" trial="" in="" acute="" myocarditis.="" acute="" myocarditis="" is="" an="" inflammatory="" condition="" of="" the="" heart="" that="" represents="" a="" leading="" cause="" of="" sudden="" cardiac="" death="" in="" children="" and="" otherwise="" healthy="" young="" adults.="" the="" most="" common="" cause="" of="" acute="" myocarditis="" is="" a="" viral="" infection="" of="" the="" heart="" tissue="" which="" is="" initially="" responsible="" for="" the="" inflammation.="" based="" on="" the="" large="" body="" of="" experimental="" evidence="" of="" the="" anti-inflammatory="" and="" cardioprotective="" properties="" of="" cannabidiol="" in="" models="" of="" cardiovascular="" disease,="" the="" company="" believes="" there="" is="" an="" opportunity="" to="" develop="" a="" potential="" breakthrough="" therapy="" for="" acute="" myocarditis="" that="" would="" be="" eligible="" for="" designation="" as="" an="" orphan="" drug.="" in="" the="" united="" states,="" an="" orphan="" drug="" designation="" is="" granted="" for="" pharmaceuticals="" being="" developed="" to="" treat="" medical="" conditions="" affecting="" fewer="" than="" 200,000="" people.="" these="" conditions="" are="" referred="" to="" as="" orphan="" diseases.="" the="" assignment="" of="" orphan="" status="" to="" a="" disease="" and="" to="" drugs="" developed="" to="" treat="" it="" is="" a="" matter="" of="" public="" policy="" in="" many="" countries="" and="" has="" yielded="" medical="" breakthroughs="" that="" might="" not="" otherwise="" have="" been="" achieved.="" in="" the="" u.s.="" and="" the="" european="" union,="" orphan="" drugs="" are="" eligible="" for="" accelerated="" marketing="" approvals="" and="" companies="" developing="" orphan="" drugs="" typically="" receive="" other="" incentives,="" including="" a="" prolonged="" period="" of="" market="" exclusivity="" that="" can="" extend="" over="" seven="" years,="" during="" which="" the="" drug="" developer="" has="" sole="" rights="" to="" market="" the="" drug.="">10>