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RECRUITING
NCT07231679
PHASE1/PHASE2

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

Sponsor: Ingenia Therapeutics INC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-10-30

Completion Date

2027-01

Last Updated

2025-12-05

Healthy Volunteers

Yes

Interventions

DRUG

IGT-303

IGT-303 administered via IV or SC

DRUG

Placebo

Saline

Locations (1)

Nucleus Network

Herston, Brisbane, Australia