Table I.
Study code | Dose cohorts (mg) | Number of subjects | PK sampling times | PD sampling times |
---|---|---|---|---|
Single ascending dose | 60 | |||
Healthy subjects | Placebo, 1, 7, 21, 70, 140, or 210 mg SC; 140 mg IV | 48 | Days 1 (pre-dose and 0.5a, 1a, and 8 h post-dose), 2–5, 8, 12, 15, 22, 29, 43, 57, 64, 85, 99, and 127 | At screening (days −21 to −2b, and day −1) and days 2c, 4c, 15, 29, 43, 64, 85, 99, 127, and 155 |
Migraine patients | Placebo or 140 mg SC | 12 | ||
Multiple ascending dose | 48 | |||
Healthy subjects | Placebo, 21, 70, 140 mg SC; | 32 | Days 1 (pre-dose and 8 h post-dose), 4, 5, 8, 12, 15, 22, 29 (pre-dose), 36, 57d (pre-dose and 8 h post-dose), 64, 71, 85, 99, 113, 127, 169d, 197d, and 224 | At screening (days −35 to −2) and days −1, 8, 57 (pre-dose), 85, 113, 169, and 197 |
280 mg x 1 + 210 mg x 2 SC | ||||
Q4W x 3 doses | ||||
Migraine patients | Placebo, 21, or 140 mg SC | 16 | ||
Q4W x 3 doses |
aPK sample collection time points required for IV cohort only
bFor IV cohort, screening DBF performed between days −21 to −4
cDBF performed on day 2 for IV cohort and on day 4 for SC cohort
dPK sample collection coincided with dermal blood flow measurement
DBF Dermal blood flow, IV Intravenous, PD Pharmacodynamic, PK Pharmacokinetic, Q4W Every 4 weeks, SC Subcutaneous