Healthy VolunteersPhase 1/2NCT07231679
A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
A Phase 1/2 study testing IGT-303 in people with Healthy Volunteers and Chronic Kidney Disease, run by Ingenia Therapeutics INC at 13 sites in 4 countries.
Trial 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)). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Chronic Kidney Disease
- What is being tested?
- IGT-303
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 30 Oct 2025to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- If taking antihypertensive and/or antidiabetic medication, doses of medications must be stable for at least 90 days prior to Screening;
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- Stable eGFR. in the opinion of the Investigator, for at least 90 days prior to Screening;
- HbA1C <9.0% 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; 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
Australia6 sites, 6 recruiting
- Recruiting
Renal Research
Gosford, New South Wales, 2250
- Recruiting
Nucleus Network
Herston, Brisbane, 4006
- Recruiting
University of the Sunshine Coast Clinical Trials-Southbank
Morayfield, Queensland, 4506
- Recruiting
University of the Sunshine Coast-Morayfield
Morayfield, Queensland, 4506
- Recruiting
Sunshine Hospital
Saint Albans, Victoria, 3021
- Recruiting
Concord Repatriation General Hospital
Sydney, New South Wales, 2139
United States4 sites, 4 recruiting
- Not yet recruiting
Balboa Nephrology - Chula Vista
Chula Vista, California, 91910
- Not yet recruiting
Clinical Research of Central Florida
Lakeland, Florida, 33805
- Not yet recruiting
Piedmont HealthCare
Statesville, North Carolina, 28625
- Not yet recruiting
Wilmington Health
Wilmington, North Carolina, 28412
New Zealand2 sites, 2 recruiting
- Recruiting
Pacific Clinical Research Network
Takapuna, Auckland, 0622
- Recruiting
Momentum Clinical Research
Waikanae Beach, Kapiti Coast, 5036
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
About this study
Official title: 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.
- Conditions
- Healthy Volunteers, Chronic Kidney Disease
- Being tested
- IGT-303, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGT-303Drug
IGT-303 administered via IV or SC
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| IGT-303 | Experimental | Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts Receives: Drug: IGT-303 |
| Placebo | Placebo comparator | Placebo (normal saline) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
The number and severity (by Grade) will be measured.
Measured: From Screening to Day 84.
Secondary outcomes (9)
PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303
Maximum observed concentration (Cmax)
Measured: Day 1 to Day 84.
PK Parameters of IV and SC IGT-303
Observed time of maximum concentration (Tmax)
Measured: 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)
Measured: Day 1 to Day 84
PK Parameters of IV and SC IGT-303
Terminal exponential half-life, calculated as ln(2)/λz (T1/2)
Measured: 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)
Measured: 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-∞)
Measured: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Total clearance (CL), defined as dose/AUC0-∞
Measured: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Terminal volume of distribution (Vz), defined as CL/λz
Measured: 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)
Measured: Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start30 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ingenia Therapeutics INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Trowbridge, MD, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231679
- Sponsor's protocol ID
- IGT-303-01-CKD01
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07231679
- Acronym / sponsor ID
- IGT-303-01-CKD01
- Conditions
- Healthy Volunteers, Chronic Kidney Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Ingenia Therapeutics INCIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGT-303 | Experimental | Drug: IGT-303Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (normal saline) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGT-303IGT-303 administered via IV or SC | Drug | IGT-303 |
| PlaceboSaline | Drug | Placebo |
Primary outcome
Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs)
Time frame: From Screening to Day 84.
The number and severity (by Grade) will be measured.
9 secondary outcomes
PK Parameters of Intravenous (IV) and Subcutaneous (SC) IGT-303
Time frame: Day 1 to Day 84.
PK Parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
PK Parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
PK Parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
PK parameters of IV and SC IGT-303
Time frame: Day 1 to Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Trowbridge, MD principal investigator
Nucleus Network
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IGT-303 in people with Healthy Volunteers and Chronic Kidney Disease, run by Ingenia Therapeutics INC at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia, United States, New Zealand, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Curry, PharmD (317-726-9118, jc@curryclinicalconsulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) (time frame: From Screening to Day 84.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.