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IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics

NCT04982705 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2022-08-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • IlDong Pharmaceutical Co Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2022-11-09
Completion
2022-12-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982705 on ClinicalTrials.gov