NCT05604287

Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects

A Placebo-controlled, Randomized, Double-blind, Single and Multiple Dose-escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects in Healthy Participants

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	ID119031166M	The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
DRUG	Placebo	The participant will receive a oral dose of Placebo.

Timeline

• Start date: 2022-10-10
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2022-11-03
• Last updated: 2024-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study