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A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Sponsor: Ingenia Therapeutics INC
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
Conditions
Interventions
IGT-303
IGT-303 administered via IV or SC
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