NCT05005065

Evaluation of the Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 in Healthy Caucasians

A Randomized, Open-label, Multiple Dosing, Cross-over Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of IN-C005 and IN-A001 After Oral Administration in Healthy Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of IN-C005 and IN-A001 after oral administration in healthy Caucasian subjects.

Detailed description

\[Part 1\] To evaluate the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and safety/tolerability of 100 mg IN-C005 versus 100 mg IN-A001 after multiple oral dosing in healthy Caucasian subjects \[Part 2\] To evaluate the PK/PD profiles and safety/tolerability of 50 mg IN-C005 versus 75 mg IN-C005 after multiple oral dosing in healthy Caucasian subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IN-C005 X mg	Oral capsule
DRUG	IN-A001 Y mg	Oral tablet
DRUG	IN-C005 Y mg	Oral capsule
DRUG	IN-C005 Z mg	Oral capsule

Timeline

• Start date: 2021-09-06
• Primary completion: 2021-11-18
• Completion: 2021-11-30
• First posted: 2021-08-13
• Last updated: 2022-05-16

Locations

2 sites across 1 country: South Korea