drugset / Trial / NCT04982705
IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-07-07
- Primary completion
- 2022-11-09
- Completion
- 2022-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sitagliptin | Small molecule | 100 mg | — |
| Subject | XELAGLIFAM | Small molecule | 0.5 mg | Oral |
| Subject | XELAGLIFAM | Small molecule | 1 mg | Oral |
| Subject | XELAGLIFAM | Small molecule | 2 mg | Oral |
| Subject | XELAGLIFAM | Small molecule | 4 mg | Oral |
| Subject | XELAGLIFAM | Small molecule | 5 mg | Oral |
| Subject | XELAGLIFAM | Small molecule | 8 mg | Oral |
| Subject | XELAGLIFAM | Small molecule | 10 mg | Oral |