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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
2027-01
Last Updated
2026-05-18
Healthy Volunteers
Yes
Conditions
Interventions
IGT-303
IGT-303 administered via IV or SC
Placebo
Saline
Locations (5)
Nucleus Network
Herston, Brisbane, Australia
University of Sunshine Coast-Morayfield
Morayfield, Queensland, Australia
University of the Sunshine Coast Clinical Trials-Southbank
Morayfield, Queensland, Australia
Pacific Clinical Research Network
Takapuna, Auckland, New Zealand
Momentum Clinical Research
Waikanae Beach, Kapiti Coast, New Zealand