Table 1.
TAK‐079 monkey studies in chronological order
| Study | Study description | Number of animals (female, male) | Dose levels (mg/kg) | Number of samples per animal (PK/PD)a |
|---|---|---|---|---|
| 1 | Day 1 (1 mg/kg) + Day 28 (2 mg/kg), IV, PK, PD | 6 (0, 6) | plc, 1, 2 | 19/10 |
| 2 | Single dose, IV, PK, PD, ADA | 9 (0, 9) | plc, 0.3, 3 | 14/9 |
| 3 | 4 weeks tox, QW, IV, PK, PD, ADA | 12 (4, 8) | plc, 1, 30, 100 | 15/8 |
| 4 | 13 weeks tox, Q2W, IV, PK, PD, ADA | 40 (20, 20) | plc, 3, 30, 80 | 28/17 |
| 5 | 13 weeks tox, QW, IV, PK, PD, ADA | 52 (26, 26) | plc, 0.1, 0.3, 1 | 31/9 |
| 6 | 13 weeks tox, QW, IV, PK, PD, ADA | 20 (20, 0) | plc, 0.1 | 31/10 |
| 7 | Single dose, IV/SC, PK, PD, ADA | 12 (12, 0) | 0.1, 0.3, 1 | 16/16 |
| 8 | Single dose, IV/SC, PK, PD | 24 (24, 0) | 0.03, 0.1, 0.3 | 19/19 |
IV, intravenous 30 minutes infusion (studies 1‐4) or bolus (studies 5‐8); SC, subcutaneous injection (single group of study 7 and 3 groups in study 8); PK, blood sampling for the assessment of TAK‐079 serum concentrations; PD, whole blood sampling for flow cytometry analyses yielding cell count data of T, B, and NK cells; ADA, anti‐TAK‐079 antibody assessment; plc, placebo; “4 weeks” or “13 weeks” describe the duration of the treatment period; tox, toxicology study; QW, weekly dosage; Q2W, every other week dosage.
a
Sample numbers are approximate or maximum numbers according to the protocol.