A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
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
Ingenia Therapeutics INC
94 participants
Oct 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Participant 18-60 years of age, inclusive, at Screening;
- Able to understand the key components of the study as described in the written informed consent document, and willing and able to provide written informed consent;
- Body mass index (BMI) within the range of 18.5 to 32 kg/m2 at Screening;
- Participants assigned male at birth (AMAB) will be either sterile or agree to use an approved method of contraception from Screening until at least 5 half-lives plus 90 days after the last dose of study drug, or do not engage in sexual relations which carry a risk of pregnancy (does include abstinence), and agree to refrain from sperm donation and in vitro fertilization until 5 half-lives plus 90 days after the last dose of the study drug;
- In the opinion of the Investigator, is able to adhere to the requirements of the study, including required overnight stays in the research site.
Exclusion Criteria4
- Known allergy to study medication or its components (non-medicinal ingredients) or a history of a severe allergic reaction to any drug or history of multiple food/drug allergies;
- Use of cigarettes exceeding \>5 cigarettes per week at time of Screening; social/casual cigarette use (≤5 per week) is permitted during the study, but participants must be willing to abstain during inpatient confinement;
- Positive urine screen for drugs of abuse including tetrahydrocannabinol or has a positive breathalyzer test, at Screening or at Day -1;
- Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data.
Interventions
IGT-303 administered via IV or SC
Saline
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07231679