NCT04982705

IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics

A Placebo- and Active-controlled, Randomised, Double-blind, Dose-escalation Phase I Study of IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics With the Exploration on Its Pharmacodynamics and Efficacy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: IlDong Pharmaceutical Co Ltd · Industry
• Sex: Male
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, first-in-human, randomised, double-blinded, placebo-and active-controlled study to assess the safety, tolerability, PK, PD, efficacy, and food-effect of IDG-16177 in healthy male subjects and patients with T2DM at different dose levels.

Detailed description

This study consists of 2 parts: Part 1 is a dose-escalation study in healthy male subjects in single ascending dose (SAD) (Part 1.1) including food-effect and multiple ascending dose (MAD) (Part 1.2) cohorts to determine the highest allowable dose (HAD) for patients with T2DM; and Part 2 is a placebo- and active-controlled efficacy exploration in patients with T2DM, insufficiently controlled with metformin alone.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	[Part 1.1] IDG-16177	\[Part 1.1\] Subjects will receive a single oral dose of IMP. Dose strenght for each cohort (Cohort 1-5) is planned as 0.5, 1, 2, 5, 10mg, respectively.
DRUG	[Part 1.1] Placebo of IDG-16177	\[Part 1.1\] subjects will receive a single oral dose of IMP.
DRUG	[Part 2] Sitagliptin	Administration of Sitagliptin 100mg once daily for 4 weeks.
DRUG	[Part1.2] IDG-16177	\[Part 1.2\] Administration once daily for 14 days; Dose strenght for each cohort (Cohort 6-8) is planned as ≤ 2, ≤ 4, ≤ 8mg, respectively.
DRUG	[Part 2] IDG-16177	\[Part 2\] Administration once daily for 4 weeks.
DRUG	[Part 1.2] Placebo of IDG-16177	\[Part 1.2\] Administration once daily for 14 days.
DRUG	[Part 2] Placebo of IDG-16177	\[Part 2\] Administration once daily for 4 weeks.

Timeline

• Start date: 2021-07-07
• Primary completion: 2022-11-09
• Completion: 2022-12-30
• First posted: 2021-07-29
• Last updated: 2022-08-11

Locations

1 site across 1 country: Germany