A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple- Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS1005 in Participants With Type 2 Diabetes
Hua Medicine Limited
Summary
The study is to assess the safety, pharmacokinetics, and pharmacodynamic profile of HMS1005 in patient with diabetes
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males or females, of any race, between 18 and 65 years of age, inclusive. 2. Body mass index between 18 and 38.0 kg/m2, inclusive. 3. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3. 4. T2DM, as determined by the ADA Standard Care Diagnostic Criteria 2025, and * are drug naïve, treated with diet and exercise, or * have been on a stable dose of ≤2000 mg metformin for ≥1 month, and/or * have been on a stable dose of other antidiabetic medications for ≥90 days. 5.…
Interventions
- DrugHMS1005
The investigational medicinal products (IMPs) HMS1005 ER tablets
- DrugMatching placebo
Matching placebo
Location
- Clinical Pharmacology of MiamiMiami, Florida