Actively Recruiting
Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects and T2D
Led by Rezubio Pharmaceuticals Co., Ltd. · Updated on 2025-08-21
134
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects and T2D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and understand study details
- Healthy males or females aged 18 to 65 years
- Body weight at least 50 kg for males and 45 kg for females
- BMI 18 to 32 kg/m2 for healthy participants; 25 to 40 kg/m2 for T2D patients
- Fasting plasma glucose between 3.9 and 6.1 mmol/L for healthy participants
- HbA1c between 6.5% and 10.5% and fasting plasma glucose ≤ 13.3 mmol/L for T2D patients
- Good general health without relevant acute or chronic medical conditions
- No significant abnormalities in vital signs, physical exam, lab tests, or ECG
- Willing and able to comply with study procedures and communicate with researchers
You will not qualify if you...
- History of allergies or multiple allergies
- Acute illness within 2 weeks before first dose or taking other medications
- History or presence of swallowing difficulties or diseases affecting drug absorption or metabolism
- Diabetes diagnosed in subject or first-degree relatives before screening
- History of hypoglycemia or impaired awareness of hypoglycemia within 3 months
- History of QT prolongation or abnormal ECG
- Major surgery within past 6 months or planned during study
- Use of medications or supplements within 2 weeks before first dose
- Consumption of caffeine, alcohol, concentrated tea, special diets, or purine-rich diets within 48 hours before first dose
- Vaccinations within 4 weeks before first dose or planned during study
- Participation in other clinical trials within 3 months before first dose or planned during study
- Blood donation or significant blood loss within specified timeframes
- Excessive alcohol use (>14 units/week) in past 12 months
- Smoking more than 5 cigarettes per day in past 3 months or inability to stop during study
- History or positive test for drug abuse
- Positive infectious disease serology at screening
- Intolerance to venipuncture or history of vasovagal syncope
- Deemed unsuitable by investigator for other reasons
- Chronic or acute gastrointestinal inflammation
- Abnormal liver function tests (ALT or AST > 2x ULN, TBIL > 1.5x ULN)
- Use of drugs affecting glucose metabolism within 1 month before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CMAX
Adelaide, Australia
Actively Recruiting
Research Team
D
Dr. Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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