Table 1.
Subject demographics and disease characteristics
| Single ascending dosea | Multiple ascending dosea | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Demographics and disease characteristics | IV | SC | SC Q4W × 4 | ||||||||
| Placebob | 1 mg | 3 mg | 10 mg | 30 mg | 10 mg | 30 mg | Placebo | 3 mg | 10 mg | 20 mg | |
| (N = 12) | (N = 6) | (N = 6) | (N = 5) | (N = 6) | (N = 5) | (N = 6) | (N = 6) | (N = 6) | (N = 6) | (N = 6) | |
| Age, years | 25.2 | 35.0 | 30.2 | 22.8 | 46.7 | 31.6 | 28.2 | 54.7 | 53.0 | 48.7 | 52.7 |
| (6.3) | (12.0) | (11.2) | (2.8) | (5.0) | (9.2) | (9.5) | (9.7) | (6.8) | (8.7) | (5.5) | |
| Weight, kg | 73.1 | 73.8 | 76.8 | 71.2 | 74.2 | 82.8 | 76.7 | 81.5 | 93.4 | 101 | 112 |
| (91) | (6.5) | (7.8) | (12.2) | (10.0) | (8.9) | (10.7) | (6.1) | (18.1) | (16.5) | (10.3) | |
| Male, % | 92 | 100 | 100 | 100 | 83 | 100 | 100 | 17 | 67 | 50 | 50 |
| Mean total WOMAC score | nac | na | na | na | na | na | na | 51.1 | 46.3 | 49.8 | 68.7 |
| (9.3) | (6.4) | (8.1) | (3.7) | ||||||||
| Mean VAS score of patients’ disease assessments | na | na | na | na | na | na | na | 35.5 | 52.3 | 48.3 | 59.0 |
| (8.3) | (8.0) | (6.6) | (6.0) | ||||||||
| Mean score of physician’s disease assessments | na | na | na | na | na | Na | na | 2.17 | 2.33 | 2.50 | 2.00 |
| (0.48) | (0.33) | (0.22) | (0.26) | ||||||||
All data are mean (SD), unless stated otherwise. aHealthy volunteers and patients with knee osteoarthritis were administered single- or multiple-doses of AMG 403, respectively. bCombined intravenous (IV) and subcutaneous (SC) placebo subjects. cNot applicable for healthy volunteer subjects. Q4W once every four weeks, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, VAS visual analog scale, na not applicable