Actively Recruiting
A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Led by Ingenia Therapeutics INC · Updated on 2026-05-04
94
Participants Needed
5
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 60 years at screening
- Able to understand the study and provide written informed consent
- Body mass index (BMI) between 18.5 and 32 kg/m2 at screening
- Participants assigned male at birth must be sterile or agree to use approved contraception from screening until 90 days after last dose, or abstain from pregnancy-risk sexual activity
- Able to follow study requirements, including overnight stays at the research site
You will not qualify if you...
- Allergy to the study drug or its components, or history of severe allergic reactions or multiple drug/food allergies
- Smoking more than 5 cigarettes per week at screening
- Positive drug abuse urine screen or breathalyzer test at screening or day before dosing
- Any illness or medical history that could affect safety, study compliance, or data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Nucleus Network
Herston, Brisbane, Australia, 4006
Actively Recruiting
2
University of Sunshine Coast-Morayfield
Morayfield, Queensland, Australia, 4506
Actively Recruiting
3
University of the Sunshine Coast Clinical Trials-Southbank
Morayfield, Queensland, Australia, 4506
Actively Recruiting
4
Pacific Clinical Research Network
Takapuna, Auckland, New Zealand, 0622
Actively Recruiting
5
Momentum Clinical Research
Waikanae Beach, Kapiti Coast, New Zealand, 5036
Actively Recruiting
Research Team
J
Jennifer Curry, PharmD
CONTACT
J
Jinsam You, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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