FIH – 24hr IV Infusion; Renal Impaired Subjects

Drug

Continuous IV Infusion for 24 hr

Multiple cohorts

Healthy volunteers split by Gender and Age

Mild and moderate Renal impairment patients

 

Strict Study timeline

Start Cohort 1 within 3 days of 31-day IND wait complete;

Start each successive cohort within 2 weeks of previous cohort end

 

Study outcome

All primary and secondary objectives met; Sponsor planning to move the drug candidate to next stage

Study completed within the sponsor target timeline

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