- The multi-site, placebo-controlled Phase 1b clinical study will enroll up to 40 subjects in up to 5 cohorts. The primary endpoint is evaluation of the safety and tolerability of a single dose of Gemini in patients with CKD. Secondary and exploratory endpoints will assess the pharmacokinetics, and the potential of Gemini to mobilize and attenuate the innate immune response to stress by measuring several predictive biomarkers of efficacy.
- Positive data from the Phase 1b study will enable a Phase 2 study of Gemini as a preconditioning treatment in patients with CKD to reduce the incidence, duration, and severity of acute kidney injury (AKI) in patients undergoing coronary artery bypass graft (CABG) and/or cardiac valve surgery.
The FDA Has Accepted Revelation Biosciences' Investigational New Drug Application To Initiate Phase 1b Study To Evaluate Gemini As A Preconditioning Treatment In Chronic Kidney Disease Patients, Study To Start In Early 2025
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