| Adverse event . | Single ascending dose . | |||||||
|---|---|---|---|---|---|---|---|---|
| . | Cohorts A, B, C (0.003–0.2 mg/kg; n = 3) . | Cohort D (0.6 mg/kg; n = 8) . | Cohort E (2 mg/kg; n = 8) . | Cohort F (6 mg/kg; n = 8) . | Cohort G (15 mg/kg; n = 8) . | Cohort H (30 mg/kg; n = 8) . | Cohort K (45 mg/kg; n = 6) . | Cohort I (60 mg/kg; n = 7) . |
| Any TEAE | 2 (66.7) | 4 (50.0) | 4 (50.0) | 7 (87.5) | 6 (75.0) | 6 (75.0) | 6 (100.0) | 6 (85.7) |
| Any treatment-related TEAE | 2 (66.7) | 2 (25.0) | 4 (50.0) | 4 (50.0) | 2 (25.0) | 5 (62.5) | 5 (83.3) | 6 (85.7) |
| Any SAE | 0 | 0 | 0 | 1 (12.5)a | 0 | 0 | 0 | 0 |
| Any treatment-related SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any TEAE leading to early disclosure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse event . | Single ascending dose . | |||||||
|---|---|---|---|---|---|---|---|---|
| . | Cohorts A, B, C (0.003–0.2 mg/kg; n = 3) . | Cohort D (0.6 mg/kg; n = 8) . | Cohort E (2 mg/kg; n = 8) . | Cohort F (6 mg/kg; n = 8) . | Cohort G (15 mg/kg; n = 8) . | Cohort H (30 mg/kg; n = 8) . | Cohort K (45 mg/kg; n = 6) . | Cohort I (60 mg/kg; n = 7) . |
| Any TEAE | 2 (66.7) | 4 (50.0) | 4 (50.0) | 7 (87.5) | 6 (75.0) | 6 (75.0) | 6 (100.0) | 6 (85.7) |
| Any treatment-related TEAE | 2 (66.7) | 2 (25.0) | 4 (50.0) | 4 (50.0) | 2 (25.0) | 5 (62.5) | 5 (83.3) | 6 (85.7) |
| Any SAE | 0 | 0 | 0 | 1 (12.5)a | 0 | 0 | 0 | 0 |
| Any treatment-related SAE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any TEAE leading to early disclosure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Data are n (%). SAE, serious adverse event; TEAE, treatment-emergent adverse event.
Traumatic injury (unrelated).