Table I.

Summary of Pharmacokinetic and Pharmacodynamic Studies

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