NCT04488900

Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects

A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, PK and PD and Food Effect of CKD-508 After Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	CKD-508 Capsule	Investigational drug
DRUG	Placebo Capsule	Placebo
DRUG	CKD-508 Tablet	Investigational drug
DRUG	Placebo Tablet	Placebo

Timeline

• Start date: 2020-07-06
• Primary completion: 2023-07-02
• Completion: 2023-07-02
• First posted: 2020-07-28
• Last updated: 2024-02-15

Locations

1 site across 1 country: United Kingdom