RecruitingPhase 1NCT06829563

Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RZ-629 in Healthy Subjects and T2D

A Phase Ia/Ib, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose/Multiple Dose Study of RZ-629 to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect in Healthy Subjects and T2D Patients.


Sponsor

Rezubio Pharmaceuticals Co., Ltd.

Enrollment

134 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety, tolerability, and how the body processes a new experimental drug called RZ-629 in both healthy adults and people with Type 2 diabetes. RZ-629 is being investigated as a potential treatment for Type 2 diabetes. **You may be eligible if...** - You are between 18 and 65 years old - You are a healthy adult with a BMI of 18–32 kg/m² (OR if you have Type 2 diabetes, a BMI of 25–40 kg/m²) - You have normal fasting blood sugar levels (if in the healthy group) - You meet minimum weight requirements (50 kg for men, 45 kg for women in the healthy group) **You may NOT be eligible if...** - You are a healthy volunteer but have elevated blood sugar or a diabetes diagnosis - You are a Type 2 diabetes participant but have very poorly controlled blood sugar or serious diabetes complications - You take medications that could interact with RZ-629 - You have significant kidney, liver, or heart problems - You are pregnant, breastfeeding, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRZ-629

Administered orally

DRUGPlacebo

Administered orally

OTHERFasted

Participants will be treated with RZ-629 in fasted or fed condition and then cross over after washout

OTHERFed

Participants will be treated with RZ-629 in fasted or fed condition and then cross over after washout


Locations(1)

CMAX

Adelaide, Australia

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NCT06829563


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