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

StatusRecruiting
PhasePhase 1/2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Oct 2026 → Dec 2026
See other at-risk trials from Ingenia Therapeutics INC

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 2026 to Dec 2026 Show 4 more changesShow less
    • Trial sites expanded: 5 → 13 locations
    • Study completion pushed from Jan 2027 to Apr 2027
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 5 of 9 entries
  2. Eligibility criteria expanded, about 158 wordsv4
  3. Study sites: 1 to 5v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2025 to Oct 30, 2025
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07231679
Lead Sponsor Ingenia Therapeutics INC
Conditions
(from sponsor)		 Healthy Volunteers, Chronic Kidney Disease
Related terms Renal Insufficiency, Chronic
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov