A Phase 1, Multiple Ascending Dose Study to Evaluate HMS1005 in Participants With Type 2 Diabetes

Part of paid clinical trials in Miami, Florida.

Sponsor
Hua Medicine Limited
Study ID
NCT07568678
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HMS1005 — DRUG
    The investigational medicinal products (IMPs) HMS1005 ER tablets
  • Matching placebo — DRUG
    Matching placebo

Study Details

The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetes

Key Dates

Start date
Dec 4, 2025
Status verified
Apr 2026
Primary completion
Aug 13, 2026
Completion
Oct 13, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 123 mg HMS1005 (1 x 123 mg tablet) and matching placebo
    active vs placebo: 6 to 2
  • Experimental: 184.5 mg HMS1005 (1 x 184.5 mg tablet) and matching placebo
    active vs placebo: 6 to 2
  • Experimental: 369 mg HMS1005 (2 x 184.5 mg tablet) and matching placebo
    active vs placebo: 6 to 2
  • Experimental: 492 mg HMS1005 (2 x 246 mg tablet) and matching placebo
    active vs placebo: 6 to 2
  • Experimental: 246 mg HMS1005 (1 x 246 mg tablet) or placebo
    active vs placebo: 6 to 2

Primary Outcome Measure

Incidence of adverse events [ Time Frame: From enrollment to the end of treatment at Day 19 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33172
Cheryl Duggan
[email protected]
305-817-2900
Alexander N Prezioso, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Clinical Pharmacology of Miami· Miami, FL

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