NCT04297865

Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.

Detailed description

* To evaluate the safety, tolerability and pharmacokinetics of single or multiple dose of CJ-15314 phosphate in healthy male subjects * To explore the pharmacodynamics of single or multiple dose of CJ-15314 phosphate in healthy male subjects * To explore the pharmacokinetics of CJ-15314 Phosphate active metabolites of single or multiple dose of CJ-15314 phosphate in healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	A dose as CJ-15314	A dose as CJ-15314, 1 capsule
DRUG	B dose as CJ-15314	B dose as CJ-15314, 1 capsule
DRUG	C dose as CJ-15314	C dose as CJ-15314, 1 capsule
DRUG	D dose as CJ-15314	D dose as CJ-15314, 2 capsules
DRUG	E dose as CJ-15314	E dose as CJ-15314, 1 capsule
DRUG	F dose as CJ-15314	F dose as CJ-15314, 2 capsules
DRUG	Placebo	Placebo, 1 capsule
DRUG	Placebo	Placebo, 1 capsule
DRUG	Placebo	Placebo, 1 capsule
DRUG	Placebo	Placebo, 2 capsules
DRUG	Placebo	Placebo, 1 capsule
DRUG	Placebo	Placebo, 2 capsules

Timeline

• Start date: 2020-02-24
• Primary completion: 2021-01-01
• Completion: 2021-02-01
• First posted: 2020-03-06
• Last updated: 2020-03-06

Locations

1 site across 1 country: South Korea