2 additional subjects in the 525 mg equivalent gluteal group had a post baseline QTcB > 480 msec and < 500 msec (Day 224 for one subject, EOS visit for other subject). 1 subject in the 350 mg equivalent gluteal had a change of > 60 ms in QTcB and QTcF from baseline (on Day 224). Injection site reactions None of them were severe in intensity or SAEs or AEs resulting in discontinuation except in 1 Panel D subject who reported severe pain in the 175 mg eq deltoid group on Day 1 of Period 2. Panel A 1 subject in the 1 mg group. 2 subjects in the 300 mg equivalent gluteal 3 subjects in the 300 mg equivalent gluteal group. Had TEAEs related to injection site reactions (pain, irritation, or rash). Panel B 1 subject in the 1 mg 3 subjects in the 300 mg equivalent deltoid group. 5 subjects in the 450 mg equivalent deltoid group. Had TEAEs related to injection site reactions (mass, pruritus, pain, induration, illness, erythema, or swelling). Panel C 2 subjects had TEAEs related to injection site reactions (warmth). Panel D 5 subjects in the 175 mg equivalent deltoid group. 5 subjects in the 525 mg equivalent deltoid group. had TEAEs related to injection site reactions (pain, nodule, erythema, swelling, induration). Maximum pain in period 2 mean pain scores were low, some patients had considerable pain. A 52/100 Day 6 300 mg gluteal 63/100 Day 2 300 mg gluteal Panel B 88/100 6 H Post-dose 75 mg equivalent Gluteal. 45/100 6 H Post-dose 150 mg equivalent Gluteal. 48/100 6 H Post-dose 300 mg equivalent Deltoid. 86/100 6 H Post-dose 450 mg equivalent Gluteal. 80/100 6 H Post-dose 450 mg equivalent Deltoid. Panel C 33/100 Day 2 150 mg gluteal 100 mg/mL.
2 additional subjects in the 525 mg equivalent gluteal group had a post baseline QTcB > 480 msec and < 500 msec (Day 224 for one subject, EOS visit for other subject). 1 subject in the 350 mg equivalent gluteal had a change of > 60 ms in QTcB and QTcF from baseline (on Day 224). Injection site reactions None of them were severe in intensity or SAEs or AEs resulting in discontinuation except in 1 Panel D subject who reported severe pain in the 175 mg eq deltoid group on Day 1 of Period 2. Panel A 1 subject in the 1 mg group. 2 subjects in the 300 mg equivalent gluteal 3 subjects in the 300 mg equivalent gluteal group. Had TEAEs related to injection site reactions (pain, irritation, or rash). Panel B 1 subject in the 1 mg 3 subjects in the 300 mg equivalent deltoid group. 5 subjects in the 450 mg equivalent deltoid group. Had TEAEs related to injection site reactions (mass, pruritus, pain, induration, illness, erythema, or swelling). Panel C 2 subjects had TEAEs related to injection site reactions (warmth). Panel D 5 subjects in the 175 mg equivalent deltoid group. 5 subjects in the 525 mg equivalent deltoid group. had TEAEs related to injection site reactions (pain, nodule, erythema, swelling, induration). Maximum pain in period 2 mean pain scores were low, some patients had considerable pain. A 52/100 Day 6 300 mg gluteal 63/100 Day 2 300 mg gluteal Panel B 88/100 6 H Post-dose 75 mg equivalent Gluteal. 45/100 6 H Post-dose 150 mg equivalent Gluteal. 48/100 6 H Post-dose 300 mg equivalent Deltoid. 86/100 6 H Post-dose 450 mg equivalent Gluteal. 80/100 6 H Post-dose 450 mg equivalent Deltoid. Panel C 33/100 Day 2 150 mg gluteal 100 mg/mL.