NCT06498284

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

HM-002-1005 - A Phase 1, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hua Medicine Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	HM-002-1005	HM-002-1005 extended release tablets for oral administration compared with matching placebo tablets

Timeline

• Start date: 2024-04-25
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2024-07-12
• Last updated: 2025-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study