A First-in-Human Study to Assess Single Doses of APNmAb005 in Healthy Participants
Status:
Not yet recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where
healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5
dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per
cohort. the starting dose of APNmAb005 is 5 mg/kg and the anticipated doses for subsequent
cohorts are 10, 25, 50 and 70 mg/kg. A Safety Review Team (SRT) will review data on an
ongoing basis throughout the study and before progression to the next dose level cohort.
Subjects will receive a single dose of either APNmAb005 or placebo administered as a single
IV infusion on Day 1 of the study and will remain in the study center until Day 3 (48 hours
after dosing). They will return to the study center for 7 outpatient visits. The duration of
the study, excluding screening, is approximately 71 days.