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Clinical Trial Summary

A Randomized, Double Blind, Parallel, Placebo-Control, Study Of ZY-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects aged between 18-55 years old (Both Inclusive).


Clinical Trial Description

Study will conduct in two parts. In Part 1; single cohort of 8 subjects. Subjects will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be randomized in a ratio of 6:2 to receive single dose of ZY-19489 or placebo orally after an overnight fast of at least 10 hours. In Part 2: study each cohort containing eight subjects will be given either a ZY19489 capsule or placebo for three consecutive days. Total three cohorts are planned in this study. Dose escalation will be performed for subsequent cohorts. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05206201
Study type Interventional
Source Cadila Healthcare Limited
Contact
Status Completed
Phase Phase 1
Start date August 25, 2021
Completion date January 21, 2022

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