IGT-303 for Chronic Kidney Disease

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

Recruiting Phase 1 Phase 2 Interventional Study
Healthy Volunteers Chronic Kidney Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
94 (estimated)
Sponsor
Ingenia Therapeutics INC · Industry
Who this trial is looking for

This trial is looking for healthy volunteers and people with chronic kidney disease. Participants will receive either the study drug IGT-303 or a placebo to help researchers check its safety.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 75 years old.
  • I can understand the study and provide written consent.
  • My BMI is between 18.5 and 40.
  • I have chronic kidney disease stage 2-3b from Type 2 diabetic nephropathy.
  • My UACR is between 30 and 5000 mg/g.
  • I have been on stable antihypertensive or antidiabetic medication for at least 90 days.
  • I am willing to follow study requirements including overnight stays.

You may not be able to join if

  • I have a known allergy to the study medication or its ingredients.
  • I smoke more than 5 cigarettes a week.
  • I tested positive for drugs or alcohol at the screening.
  • I have any illness that may affect my safety in the study.
  • I have diabetic macular edema or vitreous hemorrhage (if in Cohort 9).

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 fo…
Trial Locations
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Eligibility Criteria
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…
Contacts

Jennifer Curry, PharmD

317-726-9118

jc@curryclinicalconsulting.com

CONTACT

Jinsam You, PhD

617-440-2518

jyou@ingeniatx.com

CONTACT