Table 2.
Treatment-emergent adverse events following a single IV infusion of RPC4046 in healthy volunteers and patients with asthma
| MedDRA SOC preferred term, n (%) | Part 1: healthy volunteers | Part 2: patients with asthma | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo (n = 4) | RPC4046 single IV infusion | Placebo (n = 3) | RPC4046 single IV infusion | ||||||||
| 0.3 mg/kg (n = 4) | 1 mg/kg (n = 4) | 3 mg/kg (n = 4) | 10 mg/kg (n = 4) | Total (N = 16) | 0.3 mg/kg (n = 4) | 3 mg/kg (n = 4) | 10 mg/kg (n = 4) | Total (N = 12) | |||
| Any AE | 2 (50.0) | 3 (75.0) | 4 (100) | 3 (75.0) | 3 (75.0) | 13 (81.3) | 2 (66.7) | 3 (75.0) | 4 (100) | 2 (50.0) | 9 (75.0) |
| URTI | 0 | 2 (50.0) | 2 (50.0) | 0 | 0 | 4 (25.0) | 0 | 2 (50.0) | 1 (25.0) | 0 | 3 (25.0) |
| Viral URTI | 0 | 1 (25.0) | 1 (25.0) | 0 | 1 (25.0) | 3 (18.8) | 0 | 0 | 0 | 0 | 0 |
| Infusion site pain | 0 | 0 | 0 | 1 (25.0) | 0 | 1 (6.3) | 0 | 0 | 0 | 0 | 0 |
| Any AE at least possibly drug related | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any severe AE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any SAE | 0 | 1 (25.0)* | 0 | 0 | 0 | 1 (6.3) | 0 | 0 | 0 | 0 | 0 |
| Any AE leading to study drug discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any fatal AE | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AE adverse event, IV intravenous, MedDRA Medical Dictionary for Regulatory Activities, SAE serious AE, SOC system organ class, URTI upper respiratory tract infection
* Serious AE was a worsening foot bunion that required hospitalization for bunionectomy; the event was assessed by the investigator as moderate in severity and not related to the study drug