RecruitingPhase 1Phase 2NCT07231679

A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease

A Randomized, Placebo-Controlled, Multicenter, Phase 1/2a Study to Investigate the Safety, Tolerability, and Pharmacokinetics of IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease


Sponsor

Ingenia Therapeutics INC

Enrollment

94 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to observe the safety of IGT-303 in healthy volunteers and participants with Chronic Kidney Disease. The main question it aims to answer is: Is IGT-303 safe as a single dose or multiple dose regimen when applied under the skin (subcutaneously (SC)) or to a vein (intravenously (IV)). Researchers will compare IGT-303 against a placebo to see if IGT-303 is safe for use. Participants will be assigned to either IGT-303 or placebo and assessed for safety and tolerability for the duration of the study.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of a new drug called IGT-303 in both healthy adults and people with chronic kidney disease (CKD) — a condition where the kidneys gradually lose their ability to filter waste from the blood. Researchers want to see how the drug behaves in people with reduced kidney function. **You may be eligible if...** - You are between 18 and 60 years old - Your BMI is between 18.5 and 32 - You are generally healthy (for the healthy volunteer group) or have stable chronic kidney disease - You are willing to use reliable birth control if applicable **You may NOT be eligible if...** - You are outside the 18–60 age range - You are pregnant or breastfeeding - You have other significant medical conditions beyond stable CKD - You have taken certain medications that could interfere with the study - You have a history of drug or alcohol misuse 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

DRUGIGT-303

IGT-303 administered via IV or SC

DRUGPlacebo

Saline


Locations(5)

Nucleus Network

Herston, Brisbane, Australia

University of Sunshine Coast-Morayfield

Morayfield, Queensland, Australia

University of the Sunshine Coast Clinical Trials-Southbank

Morayfield, Queensland, Australia

Pacific Clinical Research Network

Takapuna, Auckland, New Zealand

Momentum Clinical Research

Waikanae Beach, Kapiti Coast, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07231679


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