NCT05206201

A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects

A Phase 1, Prospective, 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	ZY19489 Capsule	Two part study with single and multiple dose
DRUG	Placebo Capsule	Two part study with single and multiple dose

Timeline

• Start date: 2021-08-25
• Primary completion: 2022-01-21
• Completion: 2022-01-21
• First posted: 2022-01-25
• Last updated: 2022-07-11

Locations

1 site across 1 country: India