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.
Who can participate
Inclusion Criteria:
* 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 Criteria:
* 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.
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