A study to evaluate the pharmacokinetics, safety and tolerability after inhalation of MMI-0100 in healthy subjects; MMI-0100 is an investigational drug developed for the treatment of fibrotic indications.

MMI-0100 is a new investigational compound that may eventually be used for the
treatment of idiopathic pulmonary fibrosis and other fibrotic indications.
Fibrosis is associated with an increase of fibrous tissue in organs. This
inflammatory pulmonary disease is affected by a cascade reaction which
synthesize and release of pro-inflammatory cytokines (a cytokine is a small
protein involved in the most defense mechanisms associated with infections).
MMI-0100 inhibits a part of this cascade reaction and therefore may inhibit the
inflammation process in the lungs. This is the first time that this compound is
being given to humans.

Primary:
To determine the safety and tolerability of pulmonary administered MMI-0100
after a single dose, as assessed by adverse events (AE), vital signs, physical
exam, clinical laboratory safety assessments, lung function tests and
electrocardiography (ECG) parameters.

Secondary:
To characterize the systemic pharmacokinetics (PK) of MMI-0100 following a
single pulmonary administration.

This study is a phase I, randomized, double-blind, dose escalating,
placebo-controlled study in healthy volunteers with MMI-0100 administered by
pulmonary delivery. This is a single ascending dose study to investigate the
safety, tolerability, and PK of pulmonary administered MMI-0100 in 7 sequential
cohorts of up to 8 healthy subjects.

The study will consist of 1 period(s) during which the volunteer will receive
MMI-0100 once or placebo once. MMI-0100 and placebo will be given in the form
of an inhalation.

During the study, various studies are carried out that can be experienced as
more or less stressful.

Blood sampling, indwelling cannula:
During this study less than 200 milliliters of blood will be drawn. At Day -1
an indwelling cannula will be inserted in your arm once to collect blood on Day
1. On other days blood will be drawn using a needle inserted directly into a
vein in your arm.

Inhalation:
The study medication will be administered using the eFlow® device. The eFlow®
is a reusable electronic inhalation system designed for the treatment of
diseases of the respiratory system and lungs. Each participant will receive a
single-use hand set for the delivery of the test article.

Vital signs:
Blood pressure, pulse rate and body temperature will be measured regularly

Heart trace (ECG):
ECGs will be made regularly

Pulmonary function tests:
Pulmonary function tests will be carried out regularly at screening and during
the study. For this test you will be asked to exhale as hard as you can and to
exhale as much as you can into a special device. In addition total lung
capacity and carbon monoxide diffusion capacity will be performed in the
University Medical Center Groningen on Days -1, 1 and 15.