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

Part of paid clinical trials in Chula Vista, California.

Sponsor
Ingenia Therapeutics INC
Study ID
NCT07231679
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • IGT-303 — DRUG
    IGT-303 administered via IV or SC
  • Placebo — DRUG
    Saline

Study Details

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.

Key Dates

First listed
Nov 17, 2025
Start date
Oct 30, 2025
Status verified
Oct 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IGT-303
    Part A: single ascending dose (SAD), 6 cohorts Part B: multiple ascending dose (MAD), 3 cohorts
  • Placebo Comparator: Placebo
    Placebo (normal saline)

Primary Outcome Measure

Adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs) [ Time Frame: From Screening to Day 84. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Balboa Nephrology - Chula VistaChula VistaCalifornia91910-
Clinical Research of Central FloridaLakelandFlorida33805-
Piedmont HealthCareStatesvilleNorth Carolina28625-
Wilmington HealthWilmingtonNorth Carolina28412-

Find similar trials in Chula Vista, CA

Nationwide
Chronic kidney disease trialsNephrology trialsKidney disease trials
By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Balboa Nephrology - Chula Vista· Chula Vista, CAClinical Research of Central Florida· Lakeland, FLPiedmont HealthCare· Statesville, NCWilmington Health· Wilmington, NC

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