NCT04746287

Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

First-in-Human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of CKD-510 in Single Ascending Dose and Multiple Ascending Dose in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CKD-510 single dose	Investigational drug
DRUG	CKD-510 food effect	Investigational drug
DRUG	CKD-510 multiple dose	Investigational drug
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2020-01-14
• Primary completion: 2021-08-24
• Completion: 2021-08-24
• First posted: 2021-02-09
• Last updated: 2022-05-04

Locations

1 site across 1 country: France