A Randomized, Double Blind, Placebo Controlled, Multiple Cohort, Sequential Dose Escalation Phase 1 Clinical Study to Evaluate the Safety & Tolerability of HDCD-092330 in Healthy Volunteers

Urolithiasis is formation of stones or calculi in the urinary tract that occurs when renal stones exit the renal pelvis and move into the remainder of the urinary collecting system. These urinary stones may present with symptoms such as pain, nausea, vomiting, hematuria, burning micturition and fever. The treatment of urolithiasis is based on parameters such as the size, number, and location. Studies seem to suggest that MET may increase the likelihood of stone passage in patients with distal ureteral stones >5 mm and <10 mm in size. This is a Phase I safety study required to establish the safety of HDCD-092330 in healthy human volunteers. HDCD-092330 has been found to be safe in acute oral toxicity and repeat oral dose toxicity studies in Wistar rats with a NOAEL at maximum feasible dose levels of 1000 mg/kg b.wt. As per the guidelines, healthy volunteers usually represent the ideal model for conducting phase I clinical trials, in order to investigate drug response as well as to document safety and tolerability without interference by concomitant pathological conditions. This study is designed to be randomized, placebo controlled and double-blind study to establish unbiased safety and tolerability of HDCD-092330. In this study different set of healthy volunteers will be recruited in different cohorts in sequential manner, to minimize the carry over effect of the preceding dosing regimen.