TABLE 2.
Administration of SCTA01 and placebo in the participantsa
| Parameter | Value for: |
|||||
|---|---|---|---|---|---|---|
| SCTA01 dose group |
Total SCTA01 group (n = 25) | Placebo group (n = 8) | ||||
| 5 mg/kg (n = 3) | 15 mg/kg (n = 6) | 30 mg/kg (n = 8) | 50 mg/kg (n = 8) | |||
| Duration of observation (days) | ||||||
| Mean (SD) | 85.0 (0.0) | 84.0 (0.0) | 86.1 (4.5) | 85.5 (1.4) | 85.3 (2.7) | 84.5 (0.5) |
| Median (range) | 85.0 (85–85) | 84.0 (84–84) | 84.0 (84–97) | 85.0 (85–89) | 85.0 (84–97) | 84.5 (84–85) |
| Actual total SCTA01 dose injected (mg) | ||||||
| Mean (SD) | 302.7 (12.3) | 1,016.3 (35.4) | 1,825.9 (185.3) | 3,043.8 (392.1) | 1,838.5 (1,001.6) | |
| Median (range) | 301.5 (291–316) | 1,015.5 (977–1,064) | 1,897.5 (1,506–2,034) | 3,082.5 (2,480–3,535) | 1,872.0 (291–3,525) | |
a
The 33 participants were randomized into four cohorts as follows (SCTA01:placebo): cohort 1, 3:2 (5 mg/kg SCTA01); cohort 2, 6:2 (15 mg/kg SCTA01); cohort 3, 8:2 (30 mg/kg SCTA01); and cohort 4, 8:2 (50 mg/kg SCTA01). Participants receiving placebo in the four cohorts were pooled. SD, standard deviation.