Comparative BE for Biologics
Drug IV Biosimilar Study Design Comparative BE with Reference product PD and Immunogenicity assessments Multiple sites in EU and US In-house for few days followed by daily/weekly follow up visits Subject Recruitment Total 390 subjects AXIS as rescue site during Covid-19 peak to recruit up to 50 subjects Study outcome Studies completed within the sponsor […]
Multiple DDI studies with Post-menopausal Women
Drug Oral small-molecule prenylation inhibitor treatment of HepD Multiple studies Healthy volunteers equally split by gender Post menopausal women Subject Recruitment Timely recruitment/enrollment for all studies 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
TQT Study : Clinic and Bioanalysis completed within 2 months
Drug Continuous IV Infusion for 24 hr Study Requirements NDA submitted; FDA requested additional TQT study Corporate business target to submit asap Partnered with Clario for holter set up and ECG analysis Study Design 36 subjects 3 period Crossover: Test, Placebo, Control Study outcome Study Completed and submitted to FDA in 114 days Contract Award: […]
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; […]
