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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: IGT-303

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer Curry, PharmD; Phone Number: 317-726-9118; Email: jc@curryclinicalconsulting.com
• Study Contact Backup: Name: Jinsam You, PhD; Phone Number: 617-440-2518; Email: jyou@ingeniatx.com

Study Locations

• Australia
  • Brisbane
    • Herston, Brisbane, Australia, 4006
      • Recruiting
      • Nucleus Network
  • Queensland
    • Morayfield, Queensland, Australia, 4506
      • Recruiting
      • University of Sunshine Coast-Morayfield
    • Morayfield, Queensland, Australia, 4506
      • Recruiting
      • University of the Sunshine Coast Clinical Trials-Southbank
• New Zealand
  • Auckland
    • Takapuna, Auckland, New Zealand, 0622
      • Recruiting
      • Pacific Clinical Research Network
  • Kapiti Coast
    • Waikanae Beach, Kapiti Coast, New Zealand, 5036
      • Recruiting
      • Momentum Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant 18-75 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 40 kg/m2 at Screening;
• Have a diagnosis of chronic kidney disease stage 2-3b, resulting from Type 2 diabetic nephropathy;
• UACR >30 mg/g, <5000 mg/g at Screening and Day -1;
• If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to 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; Participants assigned female at birth (AFAB) must be of non-childbearing potential or agree to use two highly effective methods of conception from Screening until at least 5 half-lives plus 30 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 egg donation and in vitro fertilization until 5 half-lives plus 30 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;
• For participants in Cohort 9 only, have a diagnosis of nonproliferative diabetic retinopathy

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
• For participants in Cohort 9 only, presence of diabetic macular edema with anti-vascular endothelial growth factor (VEGF) treatment or vitreous hemorrhage.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (normal saline)	Drug: Placebo; Saline
Experimental: IGT-303; Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts	Drug: IGT-303; IGT-303 administered via IV or SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)	The number and severity (by Grade) will be measured.	From Screening to Day 84.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303	Maximum observed concentration (Cmax)	Day 1 to Day 84.
PK Parameters of IV and SC IGT-303	Observed time of maximum concentration (Tmax)	Day 1 to Day 84
PK Parameters of IV and SC IGT-303	Terminal exponential rate constant, determined using the linear least squares regression of the terminal phase of the log-serum concentration time profile (λz)	Day 1 to Day 84
PK Parameters of IV and SC IGT-303	Terminal exponential half-life, calculated as ln(2)/λz (T1/2)	Day 1 to Day 84
PK parameters of IV and SC IGT-303	Area under the concentration-time curve calculated using linear trapezoidal rule from time zero to time t, where t is the time of the last observed quantifiable concentration (AUC0-t)	Day 1 to Day 84
PK parameters of IV and SC IGT-303	Area under the concentration-time curve from time zero to infinity, defined as AUC0-t + Ct/λz (AUC0-∞)	Day 1 to Day 84
PK parameters of IV and SC IGT-303	Total clearance (CL), defined as dose/AUC0-∞	Day 1 to Day 84
PK parameters of IV and SC IGT-303	Terminal volume of distribution (Vz), defined as CL/λz	Day 1 to Day 84
PK parameters of IV and SC IGT-303	Absolute bioavailability (F), defined as the dose-corrected (AUC0-∞ SC) / (AUC0-∞ IV)	Day 1 to Day 84

Collaborators and Investigators

• Sponsor: Ingenia Therapeutics INC
• Investigators: Principal Investigator: Emma Trowbridge, MD, Nucleus Network

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: IGT-303-01-CKD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No