Safety and Tolerability of CFTX-1554 in Healthy Subjects
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The study will consist of 2 parts, i.e. a single ascending dose part with integrated food
effect assessment and assessment of relative bioavailability (Part A), and a multiple
ascending dose part (Part B).
Part A will have a randomized, double-blind, placebo-controlled design. Subjects will receive
single ascending doses of CFTX-1554 or placebo (as liquid formulation under fasted condition)
in 7 subsequent cohorts. Drug intake under fed conditions, and as capsule under fasted
conditions and under fed conditions (Periods 2 to 4), compared to liquid formulation under
fasted conditions (Period 1) (1 single dose level only) will be assessed.
Part B will have a randomized, double-blind, placebo-controlled design, assessing multiple
ascending oral doses of CFTX-1554 or placebo in 4 subsequent cohorts.