A1M Pharma announced that the company's preclinical GLP toxicology study with the active substance in the candidate drug ROSgard has been successfully completed, including an established dose that is now being used to calculate the doses in the company's planned clinical safety studies in humans. The company has now gathered all of the required preclinical data needed to finalize the application for initiating clinical studies with ROSgard. The clinical program is scheduled to start in the first quarter of 2018, in line with the previously communicated plan. The study design of the GLP toxicology study was rigorous and challenging, with daily injections in two different animal species during 28 consecutive days. By conducting such thorough safety studies in collaboration with CRO partner, gives great flexibility when designing the planned clinical studies. This is important to emphasize as they are designing company clinical program to eventually include kidney and bone marrow protection during radiation therapy as well as a treatment for preeclampsia, explains Eddie Thordarson. Establishing how much of the active substance in a candidate drug that is deemed safe to be given to humans is based on the No Observed Adverse Effect Level, NOAEL. Determining this level is a key factor in the design of company's clinical safety study in healthy volunteers, scheduled to start in the first quarter of 2018.