Safety, Tolerability and Pharmacokinetics ofNovel Triaminopyrimidine ZY-19489: A Randomised Double-blind Placebo-control Phase-1 Study among Healthy Indian Participants

Background: ZY-19489 is a triaminopyrimidine comprising the novel antimalarial class. Methods: This was phase-1, two-part double-blind, placebo-controlled study conducted in Ahmedabad, India. Part-1 single-dose singlecohort study. Part-2 multiple-ascending-dose Healthy participants aged 18-55 years were included. The primary objective to evaluate safety and tolerability of healthy adult Indian participants. registered with CTRI/2021/08/035449 on clinicaltrials.gov (NCT05206201). Findings: Eight enrolled part-1 (450 mg) 16 part-2, multiple ascending dose part, (two cohorts; 300 500 mg once daily for three days). All randomised 3:1 ratio (ZY-19489:placebo) within cohort. majority adverse events (AEs) reported mild severity. One six one twelve exposed ZY-19489, experienced grade-2 AEs (enteric fever, dengue, leg pain). grade-3 (GGT increase epigastric Following administration, displayed slow oral absorption median Tmax 7.5 h mean elimination half-life 90 h. administration consecutive days, day 3, maximum plasma concentration achieved at 6.25 (median Tmax) after dosing. Conclusion: well-tolerated up days. It good absorption, dose-proportional exposure, long half-life. How cite this article:Kansagra KA, Patel HB, Jansari GA, Momin T, Ghoghari A, Barot HV. Safety, Tolerability Pharmacokinetics Novel Triaminopyrimidine ZY-19489: A Randomised Double-blind Placebo-control Phase-1 Study among Participants. J Commun Dis. 2023;55(2):53-66. DOI: https://doi.org/10.24321/0019.5138.202325