NCT06829563 Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects and T2D
| NCT ID | NCT06829563 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Rezubio Pharmaceuticals Co., Ltd. |
| Condition | Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2025-12-20 |
Trial Parameters
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Brief Summary
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) biomarkers in single ascending doses (SAD), food effect, and multiple doses studies of RZ-629 in healthy participants and T2D.
Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent form (ICF) before the study, and fully understand the content, process and possible adverse reactions of the trial. 2\. Healthy male or female subjects between the ages of 18 and 65 years, inclusive. 3\. For part 1, part 2 and part 3 in healthy participants, minimum body weight is 50 kg for males, and 45 kg for females, have a BMI of 18 to 32 kg/m2, inclusive. For part 3 in T2D, BMI is between 25 to 40 kg/m2, inclusive. 4\. For part 1, part 2, and part 3 in healthy participants, fasting plasma glucose is between 3.9 mmol/L (70.2 mg/dL) and 6.1 mmol/L (109.8 mg/dL) at screening. For part 3 in T2D, glycosylated hemoglobin A1c (HbA1c) is between 6.5% and 10.5%, inclusive, and FPG ≤ 13.3 mmol/L at screening. 5\. For part 1, part 2, and part 3 in healthy participants, participants are in good health, with no clinically relevant acute or chronic medical conditions or severe diseases of the cardiovascular, gastrointestinal, hepatic, renal, endo
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