TEAEs by preferred term in 2 or more participants overall, parts 1 and 2, safety population
| . | Placebo (n = 8), n (%) . | Part 1 (SAD) elritercept, mg/kg . | Part 2 (MAD) elritercept, mg/kg . | ||||
|---|---|---|---|---|---|---|---|
| 0.05 (n = 8), n (%) . | 0.5 (n = 8), n (%) . | 1.5 (n = 8), n (%) . | 4.5 (n = 6), n (%) . | Placebo (n = 2), n (%) . | 0.75 (n = 8), n (%) . | ||
| At least 1 TEAE | 6 (75.0) | 5 (62.5) | 8 (100) | 6 (75.0) | 5 (83.3) | 2 (100) | 8 (100) |
| Hb increases | 0 | 0 | 0 | 4 (50.0) | 4 (66.7) | 0 | 4 (50.0) |
| Headache | 2 (25.0) | 1 (12.5) | 1 (12.5) | 1 (12.5) | 2 (33.3) | 2 (100) | 7 (87.5) |
| URI | 2 (25.0) | 1 (12.5) | 0 | 2 (25.0) | 1 (16.7) | NA | NA |
| Hypertension | 0 | 0 | 0 | 0 | 4 (66.7) | NA | NA |
| Nausea | 0 | 1 (12.5) | 3 (37.5) | 0 | 0 | NA | NA |
| Influenza-like illness | 0 | 1 (12.5) | 1 (12.5) | 1 (12.5) | 0 | NA | NA |
| Vomiting | 0 | 1 (12.5) | 2 (25.0) | 0 | 0 | NA | NA |
| Cough | 1 (12.5) | 0 | 1 (12.5) | 0 | 0 | NA | NA |
| Influenza | 1 (12.5) | 1 (12.5) | 0 | 0 | 0 | NA | NA |
| Toothache | 0 | 0 | 0 | 2 (25.0) | 0 | NA | NA |
| Viral URI | 0 | 0 | 0 | 1 (12.5) | 1 (16.7) | NA | NA |
| Gastroenteritis | NA | NA | NA | NA | NA | 0 | 3 (37.5) |
| Injection site erythema | NA | NA | NA | NA | NA | 0 | 3 (37.5) |
| Catheter site pain | NA | NA | NA | NA | NA | 1 (50.0) | 1 (12.5) |
| Dizziness | NA | NA | NA | NA | NA | 1 (50.0) | 1 (12.5) |
| . | Placebo (n = 8), n (%) . | Part 1 (SAD) elritercept, mg/kg . | Part 2 (MAD) elritercept, mg/kg . | ||||
|---|---|---|---|---|---|---|---|
| 0.05 (n = 8), n (%) . | 0.5 (n = 8), n (%) . | 1.5 (n = 8), n (%) . | 4.5 (n = 6), n (%) . | Placebo (n = 2), n (%) . | 0.75 (n = 8), n (%) . | ||
| At least 1 TEAE | 6 (75.0) | 5 (62.5) | 8 (100) | 6 (75.0) | 5 (83.3) | 2 (100) | 8 (100) |
| Hb increases | 0 | 0 | 0 | 4 (50.0) | 4 (66.7) | 0 | 4 (50.0) |
| Headache | 2 (25.0) | 1 (12.5) | 1 (12.5) | 1 (12.5) | 2 (33.3) | 2 (100) | 7 (87.5) |
| URI | 2 (25.0) | 1 (12.5) | 0 | 2 (25.0) | 1 (16.7) | NA | NA |
| Hypertension | 0 | 0 | 0 | 0 | 4 (66.7) | NA | NA |
| Nausea | 0 | 1 (12.5) | 3 (37.5) | 0 | 0 | NA | NA |
| Influenza-like illness | 0 | 1 (12.5) | 1 (12.5) | 1 (12.5) | 0 | NA | NA |
| Vomiting | 0 | 1 (12.5) | 2 (25.0) | 0 | 0 | NA | NA |
| Cough | 1 (12.5) | 0 | 1 (12.5) | 0 | 0 | NA | NA |
| Influenza | 1 (12.5) | 1 (12.5) | 0 | 0 | 0 | NA | NA |
| Toothache | 0 | 0 | 0 | 2 (25.0) | 0 | NA | NA |
| Viral URI | 0 | 0 | 0 | 1 (12.5) | 1 (16.7) | NA | NA |
| Gastroenteritis | NA | NA | NA | NA | NA | 0 | 3 (37.5) |
| Injection site erythema | NA | NA | NA | NA | NA | 0 | 3 (37.5) |
| Catheter site pain | NA | NA | NA | NA | NA | 1 (50.0) | 1 (12.5) |
| Dizziness | NA | NA | NA | NA | NA | 1 (50.0) | 1 (12.5) |
Note, n represents the number of participants in each category (participants with multiple events in each category are counted only once in each category); AEs were coded with MedDRA Dictionary version 22.0.
Hb, hemoglobin; MAD, multiple ascending dose; MedDRA, Medical Dictionary for Regulatory Activities; NA, not applicable; SAD, single ascending dose; TEAE, treatment-emergent adverse event; URI, upper respiratory tract infection.