A single 24-hour intravenous infusion administration of RECCE® 327 up to 12,000 mg/kg over the course of 7-days was carried out. Results of up 12,000 mg/kg/day was well tolerated from Days 1 to 4 (inclusive); with no mortalities or clinical signs. Day 5 onwards, there were indications of anticipated toxicity commencement. Some minor indications of a dosing limit were observed in some animals beyond the 7-day continuous intravenous infusion administration at 4,000 mg/kg (80x indicated efficacious dose).
As per rat 7-day repeat data, it can be concluded that there was an indication of dose limit at very high levels. A single 24-hour intravenous infusion administration of RECCE® 327 up to 4000 mg/kg and 7-day continuous intravenous infusion administration of RECCE® 327 up to 500 mg/kg/day were well tolerated; with no mortalities, clinical signs, changes in body weight, coagulation, clinical chemistry or salient macroscopic abnormalities.
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