A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease

Ingenia Therapeutics INC

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Chronic Kidney Disease; Healthy Volunteers

Treatments: Drug: IGT-303; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07231679

IGT-303-01-CKD01

Details and patient eligibility

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

IGT-303

Experimental group

Description:

Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts

Treatment:

Drug: IGT-303

Placebo

Placebo Comparator group

Description:

Placebo (normal saline)

Treatment:

Drug: Placebo