IGT-303 safety in healthy adults and people 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

This study will test whether IGT-303 is safe when given as a single or multiple dose under the skin (subcutaneous) or into a vein (intravenous) in healthy adults and people with chronic kidney disease.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Ingenia Therapeutics INC (Industry-sponsored)
• Locations: 5 sites (Herston, Brisbane and 4 other locations)
• Trial ID: NCT07231679 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 randomized, placebo-controlled trial enrolls healthy volunteers and participants with chronic kidney disease to characterize safety and tolerability of IGT-303. Participants receive single or multiple doses of IGT-303 via subcutaneous or intravenous routes or matching placebo and are closely monitored for adverse events, vital signs, and laboratory changes. The protocol includes overnight stays at research sites and scheduled follow-up visits to capture short-term safety data. Findings will guide dosing and further development decisions.

Who should consider this trial

Good fit: Adults aged 18–60 with BMI 18.5–32 kg/m2 who are either healthy volunteers or have chronic kidney disease, can give informed consent, meet contraception requirements, and can comply with overnight stays are the intended participants.

Not a fit: People outside the specified age or BMI ranges, those with a known allergy to the study drug or its components, or those unable to meet study requirements (including overnight stays or contraception rules) are unlikely to benefit from participating.

Why it matters

Potential benefit: If shown to be safe and tolerable, IGT-303 could enable further development of a new therapeutic option for people with chronic kidney disease.

How similar studies have performed: This is an early-phase safety study; while similar first-in-human/early-phase trials are a common step, success of IGT-303 in humans has not yet been established.

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.

Where this trial is running

Herston, Brisbane and 4 other locations

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

Study contacts

• Principal investigator: Emma Trowbridge, MD — Nucleus Network
• Study coordinator: Jennifer Curry, PharmD

Conditions Healthy Volunteers; Chronic Kidney Disease