Table 2.
Adverse event summary by dose cohort
|
Single ascending dose study |
Volunteer infection study |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (N=17) | 50 mg (N=6) | 100 mg (N=6) | 200 mg (N=6) | 400 mg (N=6) | 600 mg (N=6) | 1000 mg (N=6) | 1250 mg (N=6) | 1800 mg (N=6) | 2100 mg (N=1) | 150 mg (N=6) | 400 mg (N=8) | 800 mg (N=8) | ||
| Any adverse event | 13 (76%) | 6 (100%) | 5 (83%) | 3 (50%) | 4 (67%) | 3 (50%) | 4 (67%) | 5 (83%) | 6 (100%) | 1 (100%) | 6 (100%) | 8 (100%) | 7 (88%) | |
| Related to study treatment | 3 (18%) | 0 | 0 | 0 | 1 (17%) | 2 (33%) | 1 (17%) | 1 (17%) | 6 (100%) | 1 (100%) | 0 | 1 (13%) | 0 | |
| Moderate adverse event (grade 2) | 1 (6%) | 1 (17%) | 1 (17%) | 0 | 0 | 1 (17%) | 0 | 1 (17%) | 0 | 1 (100%) | 2 (33%) | 3 (38%) | 2 (25%) | |
| Related to study treatment | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17%) | 0 | 1 (100%) | 0 | 0 | 0 | |
| Severe adverse event (grade 3) | 0 | 1 (17%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (13%) | |
Data are number of participants with at least one adverse event observed after dosing with M5717 or placebo (%). There were no serious adverse events, adverse events resulting in study discontinuation, grade 3 adverse events related to study treatment, or grade 4 adverse events reported in this study. The medical assessment of adverse event severity was done in accordance with the Qualitative Toxicity Scale10 (mild=grade 1, moderate=grade 2, severe=grade 3, potentially life threatening=grade 4).