| Trial ID: | L5138 |
| Source ID: | NCT06498284
|
| Associated Drug: |
Hm-002-1005
|
| Title: |
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type II
|
| Interventions: |
DRUG: HM-002-1005
|
| Outcome Measures: |
Primary: Incidence of adverse events, incidence and severity of adverse events from Day1 to Day 11, 11 Days|Area under the plasma concentration versus time curve (AUC), area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma, 72 hour|maximum observed concentration (Cmax), Cmax of HM-002-1005 in plasma, 72 hours|time of the maximum observed concentration (Tmax), Tmax of HM-002-1005 in plasma, 72 hours|apparent terminal elimination half life (t1/2), t1/2 of HM-002-1005 in plasma, 72 hours | Secondary: glucose concentration following single oral dose of HM-002-1005, serum glucose concentration over 24 hours after dosing, 24 hours
|
| Sponsor/Collaborators: |
Sponsor: Hua Medicine Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-04-25
|
| Completion Date: |
2024-09-06
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-03
|
| Locations: |
Clinical Pharmacology of Miami, Hialeah, Florida, 33014, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06498284
|
