Clinical Trial

Experimental Type 2 Diabetes Medication in Healthy Subjects

Study Description

A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM

This is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - DA-1241

[Part1] Administration once daily for 28 days; Dose strength for each cohort (Cohort 1, 2 and 3) is planned as 50mg, 100mg and 200mg, respectively. [Part2] Administration once daily for 56 days; Dose strength for each cohort (Cohort 4, 5 and 6) is planned as 25mg, 50mg and 100mg, respectively. (Dose escalation and dose level decisions for subsequent cohorts will be made via interim dose escalation review meetings.)

Drug - Placebo

[Part1] Administration once daily for 28 days. [Part2] Administration once daily for 56 days.

Drug - Sitagliptin

[Part2] Administration of Sitagliptin 100mg once daily for 56 days.

Additional Information

Official Study Title

A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM

Clinical Trial ID

NCT03646721

ParticipAid ID

dG6v8b