Safety and Tolerability Results From a Completed Phase Sample Clauses

Safety and Tolerability Results From a Completed Phase. 1 Study in Healthy Men The Phase 1 study (study IPP-LU.01-05) was a double-blind, placebo-controlled, single- ascending-dose study to investigate the safety, tolerability, and pharmacokinetic profiles of IPP-201101 in 24 healthy men in France. Subjects were treated with an sc injection of either IPP-201101 or placebo in 3 successive treatment groups (group 1: 500 mcg, group 2: 1000 mcg, and group 3: 2000 mcg), starting with the lowest dose. Each treatment group consisted of 8 subjects and, in each group, 6 subjects received IPP-201101 and 2 subjects received placebo. Subjects were administered the next highest dose only if the preceding dose was safe and well tolerated. During the study, 3 subjects reported a total of 3 adverse events. One adverse event (transient swelling at the injection site appearing 1 hour after injection of the 2000-mcg dose) was considered by the investigator to be possibly related to study drug treatment. This adverse event was of mild intensity. The other adverse events (ie, headache and bilateral paresthesias of the abdominal wall) were reported after administration of 500 mcg of IPP- 201101 and placebo, respectively, and were of moderate intensity. Overall, local tolerability at the injection site was good. No trends or clinically relevant changes from baseline were observed in clinical laboratory test results, xxxxx xxxxx measurements, and 12-lead electrocardiogram (ECG) or physical examination findings. Although plasma samples were collected for pharmacokinetic analysis, pharmacokinetic parameters could not be calculated because the plasma concentrations were below the lower limit of quantitation of the available assay.