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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 - 75 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-10-30

Completion Date

2027-04

Last Updated

2026-10-07

Healthy Volunteers

Yes

Interventions

DRUG

IGT-303

IGT-303 administered via IV or SC

DRUG

Placebo

Saline

Locations (13)

Balboa Nephrology - Chula Vista

Chula Vista, California, United States

Clinical Research of Central Florida

Lakeland, Florida, United States

Piedmont HealthCare

Statesville, North Carolina, United States

Wilmington Health

Wilmington, North Carolina, United States

Nucleus Network

Herston, Brisbane, Australia

Renal Research

Gosford, New South Wales, Australia

Concord Repatriation General Hospital

Sydney, New South Wales, Australia

University of the Sunshine Coast Clinical Trials-Southbank

Morayfield, Queensland, Australia

University of the Sunshine Coast-Morayfield

Morayfield, Queensland, Australia

Sunshine Hospital

Saint Albans, Victoria, Australia

Pacific Clinical Research Network

Takapuna, Auckland, New Zealand

Momentum Clinical Research

Waikanae Beach, Kapiti Coast, New Zealand

Seoul National University Hospital

Seoul, South Korea