drugset / Trial / NCT06498284

Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus

NCT06498284 ↗

Phase 1 Completed 40 enrolled Hua Medicine Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

The purposes of this study are to: * Evaluate the safety and tolerability of the study drug. * Measure how much of the study drug (HM-002-1005) and its breakdown product get into the bloodstream, and how long it takes the body to get rid of them. * Measure the amount of glucose (blood sugar) and a substance called C-peptide in the bloodstream after receiving the study drug. Researchers will compare the study drug to a placebo (a look-alike substance that contains no drug). Participants will: * Stay 5 days and 4 nights or 6 days and 5 nights at the research site, and have a follow-up phone call 7 days after leaving the research site. * Take one (1) dose of the study drug or placebo * Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide * Have safety tests such as vital sign, ECGs, and glucose measurements

Timeline

Start
2024-04-25
Primary completion
2024-09-06
Completion
2024-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject HM-002-1005 Unknown 61.5 mg Oral
Subject HM-002-1005 Unknown 123 mg Oral
Subject HM-002-1005 Unknown 184.5 mg Oral
Subject HM-002-1005 Unknown 246 mg Oral
Subject HM-002-1005 Unknown 369 mg Oral