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• W2022358970 abstract "RationaleJDP-205 and JDP-207 are developed as novel, first-in-class therapy for acute allergic reactions. JDP-205 intravenous injection is aimed for a faster or immediate onset treatment profile for hospital use, while JDP-207 is an intramuscular formulation designed for patient self auto-injection to alleviate urticaria associated with acute allergic reactions. This Phase-I clinical study was designed to assess their safety and tolerability when administered to human volunteers.MethodsTwenty-four healthy volunteers were randomized in a 4-period design. The drug products were provided as sterile small volume parenteral injectable products. Single doses of JDP-205 were administered by intravenous injection over 1.5-minute, while JDP-207 was administered by intramuscular injection in the anterolateral thigh muscle slowly within 0.5-minute. Blood samples were collected up to 36-hours. Safety was evaluated through laboratory tests, vital signs, electrocardiogram and adverse events. Some key adverse events were recorded prior to and 3 times after drug administration.ResultsDuring the study, 22 (91.7%) subjects experienced a total of 66 adverse events; severity ranged from mild to moderate, except for intramuscular injection site pain. No subject took concomitant medications and no subject was withdrawn for safety reasons. The JDP-205 intravenous doses were deemed proportional on drug exposure over 36-hours. Over a scale of 0-10, the key adverse events were reported at a mean score of 0 (none, SD 0) by all subjects.ConclusionsJDP-205 and JDP-207 were judged safe, well-tolerated by the human volunteers. Both products represent promising novel and superior treatment to the current therapy by eliminating many side effects of the current therapy. RationaleJDP-205 and JDP-207 are developed as novel, first-in-class therapy for acute allergic reactions. JDP-205 intravenous injection is aimed for a faster or immediate onset treatment profile for hospital use, while JDP-207 is an intramuscular formulation designed for patient self auto-injection to alleviate urticaria associated with acute allergic reactions. This Phase-I clinical study was designed to assess their safety and tolerability when administered to human volunteers. JDP-205 and JDP-207 are developed as novel, first-in-class therapy for acute allergic reactions. JDP-205 intravenous injection is aimed for a faster or immediate onset treatment profile for hospital use, while JDP-207 is an intramuscular formulation designed for patient self auto-injection to alleviate urticaria associated with acute allergic reactions. This Phase-I clinical study was designed to assess their safety and tolerability when administered to human volunteers. MethodsTwenty-four healthy volunteers were randomized in a 4-period design. The drug products were provided as sterile small volume parenteral injectable products. Single doses of JDP-205 were administered by intravenous injection over 1.5-minute, while JDP-207 was administered by intramuscular injection in the anterolateral thigh muscle slowly within 0.5-minute. Blood samples were collected up to 36-hours. Safety was evaluated through laboratory tests, vital signs, electrocardiogram and adverse events. Some key adverse events were recorded prior to and 3 times after drug administration. Twenty-four healthy volunteers were randomized in a 4-period design. The drug products were provided as sterile small volume parenteral injectable products. Single doses of JDP-205 were administered by intravenous injection over 1.5-minute, while JDP-207 was administered by intramuscular injection in the anterolateral thigh muscle slowly within 0.5-minute. Blood samples were collected up to 36-hours. Safety was evaluated through laboratory tests, vital signs, electrocardiogram and adverse events. Some key adverse events were recorded prior to and 3 times after drug administration. ResultsDuring the study, 22 (91.7%) subjects experienced a total of 66 adverse events; severity ranged from mild to moderate, except for intramuscular injection site pain. No subject took concomitant medications and no subject was withdrawn for safety reasons. The JDP-205 intravenous doses were deemed proportional on drug exposure over 36-hours. Over a scale of 0-10, the key adverse events were reported at a mean score of 0 (none, SD 0) by all subjects. During the study, 22 (91.7%) subjects experienced a total of 66 adverse events; severity ranged from mild to moderate, except for intramuscular injection site pain. No subject took concomitant medications and no subject was withdrawn for safety reasons. The JDP-205 intravenous doses were deemed proportional on drug exposure over 36-hours. Over a scale of 0-10, the key adverse events were reported at a mean score of 0 (none, SD 0) by all subjects. ConclusionsJDP-205 and JDP-207 were judged safe, well-tolerated by the human volunteers. Both products represent promising novel and superior treatment to the current therapy by eliminating many side effects of the current therapy. JDP-205 and JDP-207 were judged safe, well-tolerated by the human volunteers. Both products represent promising novel and superior treatment to the current therapy by eliminating many side effects of the current therapy." @default.
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• W2022358970 date "2013-02-01" @default.
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• W2022358970 title "A Phase I Assessment of the Safety and Tolerability Profile of Novel Treatments for Acute Allergic Reactions Administered by Intravenous and Intramuscular Injection Formulations" @default.
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