NCT06736912

This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of IN-114199 in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, Single/multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety/tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 63 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants

Detailed description

Part A: SAD and FES study * To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults * To compare and evaluate the effects of food on the safety, tolerability, pharmacokinetic and pharmacodynamic properties of a single oral dose of IN-114199 in healthy adults Part B: MAD study \- To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of repeated oral doses of IN-114199 in healthy adults

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	IN-114199 2.5mg or placebo	IN-114199 2.5mg or placebo (1 Tablet, QD)
DRUG	IN-114199 10mg or placebo	IN-114199 10mg or placebo (1 Tablet, QD)
DRUG	IN-114199 20mg or placebo	IN-114199 10mg or placebo (2 Tablets, QD)
DRUG	IN-114199 40mg or placebo	IN-114199 10mg or placebo (4 Tablets, QD)
DRUG	IN-114199 5mg or placebo	IN-114199 2.5mg or placebo (2 Tablets, QD)

Timeline

• Start date: 2024-12-16
• Primary completion: 2025-08-30
• Completion: 2025-11-11
• First posted: 2024-12-17
• Last updated: 2024-12-17

Locations

1 site across 1 country: South Korea