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A Phase 1b, Randomized, Placebo-Controlled, Single-Blind, Single Ascending Dose Study in Subjects With Stage 3 or 4 Chronic Kidney Disease

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Trial Profile

A Phase 1b, Randomized, Placebo-Controlled, Single-Blind, Single Ascending Dose Study in Subjects With Stage 3 or 4 Chronic Kidney Disease

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Aug 2025

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At a glance

  • Drugs Glycopyranosyl lipid adjuvant (Primary)
  • Indications Renal failure
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PRIME
  • Sponsors Revelation Biosciences

Most Recent Events

  • 16 Jul 2025 According to a Revelation Biosciences media release, several study data sets are expected during Q3 2025: these will include safety parameters, changes in hematologic parameters, in vitro evaluation of the inflammatory response in peripheral blood mononuclear cells isolated from study participants, and multiple biomarkers of activity.
  • 16 Jul 2025 According to a Revelation Biosciences, the company announced dosing has been completed for the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of escalating doses of intravenously administered Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD).
  • 08 May 2025 According to a Revelation Biosciences, company completed dosing of first patient in PRIME Phase 1b Clinical Study of Gemini in CKD Patients and topline data to be presented this summer.

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