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NCT07231679
A Study to Investigate IGT-303 in Healthy Volunteers and Participants With Chronic Kidney Disease
Conditions: Healthy Volunteers, Chronic Kidney Disease
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE1, PHASE2
Enrollment: 94
Sponsor: Ingenia Therapeutics INC
Location: Balboa Nephrology - Chula Vista Chula Vista California
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.
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 kg/m2 at Screening;
* Have a diagnosis of chronic kidney disease stage 2-3b, resulting from Type 2 diabetic nephropathy;
* UACR \>30 mg/g, \
Source: ClinicalTrials.gov (NCT07231679). StuddyBuddy aggregates publicly available trial information.