Gemini is being evaluated in a placebo controlled, single dose, escalating dose study to evaluate the safety and tolerability of intravenous Gemini in adult subjects with stage 3 or 4 chronic kidney disease. Pharmacokinetics will be evaluated and measurements of the effect of Gemini on pharmacodynamic activity will be measured to assess changes in potential pharmacodynamic markers.
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Effect of Gemini versus placebo on the incidence of treatment-emergent adverse events.
Timeframe: From time of dose to Day 8
Effect of Gemini vs placebo on electrical activity of the heart.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on blood pressure.
Timeframe: From time of dose to Day 8
Number of participants with abnormal laboratory hematology test results.
Timeframe: From time of dose to Day 8
Number of participants with abnormal laboratory chemistry tests results.
Timeframe: From time of dose to Day 8
Number of participants with abnormal laboratory urine tests results.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on inflammation in the body.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on inflammation.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on the inflammatory state of CKD subjects.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on kidney damage.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on heart rate.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on body temperature.
Timeframe: From time of dose to Day 8
Effect of Gemini versus placebo on respiration.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings.
Timeframe: From time of dose to Day 8
Number of participants with abnormal mental physical exam findings.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings above the shoulders.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the skin.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the heart.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the lungs.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the digestive system.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the body's support structure.
Timeframe: From time of dose to Day 8
Number of participants with abnormal physical exam findings of the nervous system.
Timeframe: From time of dose to Day 8