First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers

Inclusion Criteria:

- Healthy male and female participants 18 to 55 years of age included, and in good
health as determined by past medical history, physical examination, vital signs,
electrocardiogram, and laboratory tests at screening.

- Participants must weigh at least 50 kg to participate in the study, and must have a
body mass index (BMI) within the range of 18.0 - 30.0 kg/m2. BMI = Body weight (kg)
/ [Height (m)]2

- At screening and baseline, vital signs (systolic and diastolic blood pressure and
pulse rate) will be assessed in the supine position after the participant has rested
for at least three (3) minutes, and again in the standing position. Supine vital
signs should be within the following ranges:

- oral body temperature between 35.0-37.5 °C

- systolic blood pressure, 90-139 mmHg

- diastolic blood pressure, 50-89 mmHg

- pulse rate, 40-90 bpm

Exclusion Criteria:

- Participants who have received any IMP in a clinical research study within 90 days
or 5 half-lives of enrollment, whichever is longer; or longer if required by local
regulations.

- History of multiple and recurring allergies or allergy or hypersensitivity to any of
the study treatments, excipients or drugs of similar chemical classes. Hay fever is
allowed unless it is active at time of screening or if there is a risk that it may
become active during the study.

- Pregnant or nursing (lactating) women, assessed at screening and baseline.

- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant.

- Sexually active males unwilling to use a condom during intercourse while taking
investigational drug and for 7 days after stopping the investigational drug.

Additional protocol-defined inclusion / exclusion criteria may apply.