Table 1.
Summary of treatment-emergent adverse events related to study drug for total period
| Low N = 9 | High N = 9 | Placebo N = 6 | Total N = 24 | |
|---|---|---|---|---|
| Subjects with at least one related TEAE | 9 (100%) | 4 (44%) | 4 (67%) | 17 (71%) |
| Nervous system disorders | 5 (56%) | 0 | 2 (33%) | 7 (29%) |
| Dizziness | 1 (11%) | 0 | 0 | 1 (4%) |
| Head discomfort | 1 (11%) | 0 | 0 | 1 (4%) |
| Headache | 5 (56%) | 0 | 2 (33%) | 7 (29%) |
| Cardiac disorders | 0 | 0 | 1 (17%) | 1 (4%) |
| Palpitations | 0 | 0 | 1 (17%) | 1 (4%) |
| Respiratory, thoracic and mediastinal disorders | 1 (11%) | 0 | 0 | 1 (4%) |
| Cough | 1 (11%) | 0 | 0 | 1 (4%) |
| Gastrointestinal disorders | 2 (22%) | 0 | 1 (17%) | 3 (13%) |
| Abdominal distension | 1 (11%) | 0 | 0 | 1 (4%) |
| Abdominal pain | 1 (11%) | 0 | 0 | 1 (4%) |
| Bowel movement irregularity | 0 | 0 | 1 (17%) | 1 (4%) |
| Diarrhea | 1 (11%) | 0 | 0 | 1 (4%) |
| Nausea | 1 (11%) | 0 | 1 (17%) | 2 (8%) |
| Vomiting | 1 (11%) | 0 | 1 (17%) | 2 (8%) |
| General disorders and administration site conditions | 8 (89%) | 4 (44%) | 3 (50%) | 15 (63%) |
| Feeling hot | 1 (11%) | 0 | 0 | 1 (4%) |
| Injection site bruising | 0 | 0 | 1 (17%) | 1 (4%) |
| Injection site erythema | 1 (11%) | 2 (22%) | 0 | 3 (13%) |
| Injection site mass | 0 | 1 (11%) | 0 | 1 (4%) |
| Injection site pain | 8 (89%) | 4 (44%) | 1 (17%) | 13 (54%) |
| Injection site pruritus | 1 (11%) | 0 | 0 | 1 (4%) |
| Injection site swelling | 0 | 0 | 1 (17%) | 1 (4%) |
Total period means V0 to B360 (360 days after the second dose) excluding Placebo after B90
Low low dose of AGMG0201, High high dose of AGMG0201, Placebo Saline