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
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
美國食品藥品監督管理局已接受Revelation Biosciences的臨床新藥申請，以開始對Gemini進行爲期10億的研究，評估其作爲慢性腎病患者的預處理治療，研究預計將在2025年初啓動。
- 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.
- 該多中心、安慰劑對照的Phase 10億臨床研究將招募多達40名受試者，分爲最多5個隊列。主要終點是評估Gemini在慢性腎病（CKD）患者中單劑量的安全性和耐受性。次要和探索性終點將評估藥代動力學，以及Gemini動員和減輕對壓力的先天免疫反應的潛力，通過測量幾個有效性預測生物標誌物來實現。
- Phase 10億研究中的積極數據將使Gemini作爲慢性腎病（CKD）患者的預處理治療的Phase 2研究得以進行，以減少接受冠狀動脈旁路移植（CABG）和/或心臟瓣膜手術的患者急性腎損傷（AKI）的發生率、持續時間和嚴重程度。
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