Table 1.

Study design and demographics summary

					No. of observations
Study description (study #)	Population	No. of participants	Benralizumab route/dosage	Blood sampling schedule	Serum benralizumab	Eosinophil count
Phase I, single ascending dose (KHK4563‐001)	Healthy Japanese individuals	30	i.v. 0.03–3 mg/kg single dose	PK: intensive up to day 84 PD: predose, 6 h, and up to day 84	492	355
Phase I, single ascending dose (KHK4563‐002)	Healthy Japanese individuals	18	s.c. 25, 100, 200 mg single dose	PK: intensive up to day 84 PD: predose, 6 h, and up to day 84	252	216
Phase I, single ascending dose (MI‐CP158)	Adults w/asthma, USA	44	i.v. 0.0003–3 mg/kg single dose	PK: intensive up to day 84 PD: predose and days 1, 2, 7, 58, and 84	553	552
Phase I, randomized, double‐blind, placebo‐controlled dosage‐increase (MI‐CP166)	Adults w/asthma, USA	17	i.v. 1 mg/kg single dose (cohort 1) s.c. 100 or 200 mg every 4 weeks × 3 (cohort 2)	Cohort 1: PK/PD sampling up to day 84 Cohort 2: PK/PD sampling up to day 140	125	143
Phase II, randomized, double‐blind, placebo‐controlled (MI‐CP186)	Adults w/asthma, USA	72	i.v. 0.3 or 1 mg/kg single dose	PK: predose, 1 h, and days 7, 42, and 84 PD: predose and days 7, 42, and 84	257	217
Phase II, randomized, double‐blind, placebo‐controlled dosage increase (MI‐CP197)	Adults w/asthma, USA	19	s.c. 25, 100, or 200 mg every 4 weeks × 3	PK: predose and days 1, 7, 28, 35, 56, 84, 112, and 161 PD: predose and days 1, 7, 28, 56, 84, 112, and 161	141	181

PD, pharmacodynamics; PK, pharmacokinetics.