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

NCT07231679 | Recruiting Phase 1 DMC

• 1 other identifier: IGT-303-01-CKD01
• Study Type: interventional
• Target: 94
• Locations: 2 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303

  Day 1 to Day 84.

• PK Parameters of IV and SC IGT-303

  Day 1 to Day 84

• PK Parameters of IV and SC IGT-303

  Day 1 to Day 84

• PK Parameters of IV and SC IGT-303

  Day 1 to Day 84

• PK parameters of IV and SC IGT-303

  Day 1 to Day 84

Study Arms (2)

IGT-303

EXPERIMENTAL

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

Drug: IGT-303

Placebo

PLACEBO COMPARATOR

Placebo (normal saline)

Drug: Placebo

Interventions

IGT-303 DRUG

IGT-303 administered via IV or SC

IGT-303

Placebo DRUG

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ingenia Therapeutics INC: lead

Study Sites (5)

Nucleus Network

Herston, Brisbane, 4006, Australia

RECRUITING

University of Sunshine Coast-Morayfield

Morayfield, Queensland, 4506, Australia

RECRUITING

University of the Sunshine Coast Clinical Trials-Southbank

Morayfield, Queensland, 4506, Australia

RECRUITING

Pacific Clinical Research Network

Takapuna, Auckland, 0622, New Zealand

RECRUITING

Momentum Clinical Research

Waikanae Beach, Kapiti Coast, 5036, New Zealand

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma Trowbridge, MD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Curry, PharmD

CONTACT

317-726-9118; jc@curryclinicalconsulting.com

Jinsam You, PhD

CONTACT

617-440-2518; jyou@ingeniatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); NZ (2)