Table 6.
Treatment‐Related Adverse Events
| A. Single Ascending Doses | |||||
|---|---|---|---|---|---|
| System Organ Class/Preferred Term | Placebo (N = 8) n (%) | Cohort A GSK3389404 10 mg (N = 6) n (%) | Cohort B GSK3389404 30 mg (N = 6) n (%) | Cohort C GSK3389404 60 mg (N = 6) n (%) | Cohort D GSK3389404 120 mg (N = 6) n (%) |
| Any related event | 1 (13) | 0 | 2 (33) | 0 | 5 (83) |
| General disorders and administration site conditions | |||||
| Any event | 1 (13) | 0 | 0 | 0 | 3 (50) |
| Injection site bruising | 0 | 0 | 0 | 0 | 1 (17) |
| Injection site erythema | 0 | 0 | 0 | 0 | 2 (33) |
| Injection site pain | 1 (13) | 0 | 0 | 0 | 0 |
| Investigations | |||||
| Any event | 0 | 0 | 0 | 0 | 1 (17) |
| ALT increased | 0 | 0 | 0 | 0 | 1 (17) |
| AST increased | 0 | 0 | 0 | 0 | 1 (17) |
| Nervous system disorders | |||||
| Any event | 0 | 0 | 2 (33) | 0 | 1 (17) |
| Headache | 0 | 0 | 2 (33) | 0 | 1 (17) |
| B. Multiple Ascending Doses | ||||
|---|---|---|---|---|
| System Organ Class/Preferred Term | Placebo (QW × 4 weeks) (N = 6) n (%) | Cohort E GSK3389404 30 mg (QW × 4 weeks) (N = 6) n (%) | Cohort F GSK3389404 60 mg (QW × 4 weeks) (N = 6) n (%) | Cohort G GSK3389404 120 mg (QW × 4 weeks) (N = 6) n (%) |
| Any related event | 1 (17) | 4 (67) | 1 (17) | 2 (33) |
| General disorders and administration site conditions | ||||
| Any event | 1 (17) | 3 (50) | 0 | 2 (33) |
| Injection site erythema | 1 (17) | 2 (33) | 0 | 2 (33) |
| Injection site discomfort | 0 | 1 (17) | 0 | 0 |
| Injection site pain | 0 | 0 | 0 | 1 (17) |
| Injection site pruritus | 0 | 1 (17) | 0 | 0 |
| Injection site swelling | 0 | 1 (17) | 0 | 0 |
| Metabolism and nutrition disorders | ||||
| Any event | 0 | 1 (17) | 0 | 0 |
| Decreased appetite | 0 | 1 (17) | 0 | 0 |
| Nervous system disorders | ||||
| Any event | 1 (17) | 2 (33) | 1 (17) | 0 |
| Dizziness | 0 | 1 (17) | 0 | 0 |
| Headache | 0 | 1 (17) | 1 (17) | 0 |
| Somnolence | 1 (17) | 0 | 0 | 0 |
Safety population: defined as all subjects who received ≥1 dose of GSK3389404 or placebo. ALT indicates alanine aminotransferase; AST, alanine aminotransferase; N, total number of subjects; n, number of subjects with observation; QW, once weekly.