TABLE 1.

Overview of the 2 Phase I studies on emodepside

	SAD study (first‐in‐human study)	MAD study
Design features	Two‐part, single‐centre, double‐blind, randomised, placebo‐controlled, parallel group, single ascending dose, comparative study	Single‐centre, double‐blind, randomised, placebo‐controlled, parallel‐group, multiple ascending dose study
Study groups	10 cohorts of 8 subjects each; 6 on emodepside, 2 on placebo	3 cohorts of 8 subjects each; 6 on emodepside, 2 on placebo
Study population	Healthy male subjects aged 18–55 y	Healthy male subjects aged 18–45 y
Objectives	Cohorts 1 to 8: Assess safety, tolerability and PK of single ascending oral doses Cohort 9: Assess food effect on bioavailability of LSF Cohort 10: Explore relationship between emodepside and AEs reported in part 1, in particular ophthalmological events	Assess safety, tolerability, PK and PD of multiple ascending oral doses of LSF over 10 days
Doses studied	Cohorts 1 to 8: LSF at 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 40 mg under fasting conditions; IR tablet: 5 mg or 20 mg under fasting conditions; Cohort 9: LSF at 10 mg under fed conditions; Cohort 10: LSF at 40 mg under fasting conditions	Cohort 1: 5 mg once daily for 10 days; cohort 2: 10 mg once daily for 10 days; cohort 3: 10 mg twice daily for 10 days (single intake on last day)
Dose escalation	Upon safety committee decision	Upon safety committee decision

AE: adverse event; IR: immediate release; LSF: liquid service formulation; MAD: multiple ascending dose; PD: pharmacodynamics; PK: pharmacokinetics; SAD: single ascending dose.