A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers

Approximately 35 participants are planned to be screened to achieve 20 randomised participants and at least 16 evaluable participants in Part I.

All participants who complete Part I will continue in Part II.

Each participant is expected to participate in the trial for approximately 9 to 13 weeks (depending on the length of each wash-out period), including a 28-day screening period.

Part I: Participants will self-administer EMP22 for 9 days and Xenical® for 9 days (TID dosing) at home. EMP22 and Xenical® should be taken halfway through each of the 3 main meals during the day (breakfast, lunch, dinner) with approximately 50 to 200 mL water.

EMP22 and Xenical® have different strengths of orlistat, 60 mg and 120 mg, respectively. In order to maintain the blind for the participants, the IMP will be administered as follows:

* EMP22 60 mg orlistat, 2 capsules TID. * Xenical® 120 mg orlistat 1 capsule + placebo 1 capsule TID.

Part II: Following an overnight fast of at least 8 hours and a light standardised breakfast upon admission (approximately 2 hours prior to dose), EMP16 will be taken halfway through a regular standardised breakfast (5 minutes after the start of the meal, which is expected to be finished in 10 minutes) with approximately 50 to 200 mL water. After a 4-14 day washout, the same procedure will be repeated using Xenical® .

The participants will receive a single dose dose of EMP16 (2 capsules, each of 60 mg) and a single dose of Xenical® (1 capsule, 120 mg).