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

NCT ID: NCT07231679

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2027-01-31

Brief 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.

Conditions

Healthy Volunteers; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IGT-303

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

Group Type: EXPERIMENTAL

IGT-303

Intervention Type: DRUG

IGT-303 administered via IV or SC

Placebo

Placebo (normal saline)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline

Interventions

IGT-303

IGT-303 administered via IV or SC

Intervention Type: DRUG

Placebo

Saline

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ingenia Therapeutics INC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma Trowbridge, MD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

Nucleus Network

Herston, Brisbane, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Jennifer Curry, PharmD

Role: CONTACT

jc@curryclinicalconsulting.com

317-726-9118

Jinsam You, PhD

Role: CONTACT

jyou@ingeniatx.com

617-440-2518

Other Identifiers

IGT-303-01-CKD01

Identifier Type: -

Identifier Source: org_study_id