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

NCT06498284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-03

No results posted yet for this study

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

DRUG

HM-002-1005

HM-002-1005 extended release tablets for oral administration compared with matching placebo tablets

Sponsors & Collaborators

  • Hua Medicine Limited

    lead INDUSTRY

Principal Investigators

  • Alexander N Prezioso, MD · Clinical Pharmacology of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2024-09-06
Completion
2024-09-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06498284 on ClinicalTrials.gov