Healthy Volunteers Clinical Trial
Official title:
A First-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetics of anle138b in Healthy Male and Female Subjects
The purpose of this study is to determine the safety, tolerability and blood levels of orally administered anle138b in healthy subjects.
This is a single-centre, study of double-blind, randomised, placebo-controlled single
ascending doses (SAD) and multiple ascending doses (MAD) of anle138b in healthy subjects in
study Parts 1 and 2. In study Part 3 the effect of food (FES) on the safety and PK of
anle138b in healthy subjects is examined.
In the SAD cohorts, subjects will be randomly assigned to receive a single oral dose of
active investigational medicinal product (IMP) or matching placebo in a sequential escalating
manner with sufficient time planned between dose groups to allow interim review of the data.
In the MAD cohorts, subjects will be randomly assigned to receive oral doses of active IMP or
matching placebo once daily (QD) for 7 days, in a sequential escalating manner with
sufficient time planned between dose groups to allow interim review of the data.
In the FES, the effect of food on the safety and PK of anle138b is explored by administering
a single dose of IMP after a high-fat breakfast. Subjects will be randomly assigned to one of
2 treatment sequence to receive anle138b in the fed or fasted state over 2 periods.
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