Study to Evaluate Safety and Effects of IGT-303 in Adults With Chronic Kidney Disease and Healthy Volunteers

What this Trial Is About

Researchers are evaluating the safety of IGT-303 in healthy volunteers and people with Chronic Kidney Disease CKD, particularly those with stage 2-3b CKD due to Type 2 diabetic nephropathy. This clinical trial aims to determine if IGT-303 is safe when given as a single dose or multiple doses under the skin subcutaneous or into a vein intravenous. The study compares IGT-303 to a placebo to assess safety and tolerability. Participants will be randomly assigned to receive either IGT-303 or a placebo, with treatments given as a single ascending dose in six groups Part A or multiple ascending doses in three groups Part B. The placebo used is normal saline. The study includes both single and multiple dose phases, with monitoring over time. During the study, participants will be assessed for adverse events and treatment-emergent side effects from screening until day 84. Researchers will also measure how the body processes IGT-303 through pharmacokinetic tests during this period. Participants may have overnight stays at the research site and will be followed closely to monitor safety and treatment effects throughout the study duration.

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