NCT07231679

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Ingenia Therapeutics INC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	IGT-303	IGT-303 administered via IV or SC
DRUG	Placebo	Saline

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2025-11-17
• Last updated: 2025-12-05

Locations

1 site across 1 country: Australia