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

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the trial.
2. Healthy male or female aged 20 to 55 years inclusive.
3. Participants with a BMI between 20 and 27 kg/m² or participants with a BMI >27 kg/m2and normal body fat composition (10 to 25% for men and 20 to 30% for women measuredusing a bioimpedance scale) at screening.
4. Weight stable (<5% self-reported change during the previous 3 months precedingscreening).
5. Participants with a self-perceived normality in defecation habits, normally with astool frequency of at least once daily.
6. Medically healthy participant without abnormal clinically significant medical history,physical findings, vital signs, electrocardiogram (ECG) and laboratory values at thetime of the screening visit, as judged by the Investigator.

Exclusion Criteria:

1. History of any clinically significant disease or disorder which, in the opinion of theInvestigator, may either put the participant at risk because of participation in thetrial, or influence the results or the participant's ability to participate in thetrial including but not limited to:

• GI problems/diseases, e.g. inflammatory bowel diseases and irritable bowelsyndrome (IBS).
• Cholestasis.
• Previous GI surgery that might influence GI function significantly, such asprevious bariatric surgery, and previous gallbladder surgery as judged by theinvestigator.
• Vitamin B12 deficiency or other signs of achlorhydria.
• Chronical malabsorption syndrome.
• History of severe allergic, cardiac or hepatic disease.

2. Any clinically significant illness, medical/surgical procedure or trauma within 4weeks of the first administration of IMP.
3. Malignancy within the past 5 years, with the exception of in situ removal of basalcell carcinoma.
4. Any planned major surgery within the duration of the trial.
5. Participants who are pregnant, currently breastfeeding, or intend to become pregnantduring the course of the trial.
6. Any positive result at the screening visit for serum hepatitis B surface antigen,hepatitis C antibodies and/or human immunodeficiency virus (HIV).
7. Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significantabnormalities in the resting ECG at the screening visit, as judged by theInvestigator.
8. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, asjudged by the Investigator, or history of hypersensitivity to drugs with a similarchemical structure or class as orlistat or acarbose.
9. Regular use of any prescribed or non-prescribed medications (including, but notlimited to, antacids, analgesics, herbal remedies, vitamins and minerals) within 2weeks prior to the first administration of IMP except as outlined in Section 9.6.2.3.
10. Administration of another new chemical entity (defined as a compound which has notbeen approved for marketing) or has participated in any other clinical trial thatincluded drug treatment within 3 months of the first administration of IMP in thistrial. Subjects consented and screened but not dosed in previous studies are notexcluded.
11. Current smokers or users of nicotine products. Irregular use of nicotine (e.g.,smoking, snuffing, chewing tobacco) less than 3 times/week is allowed before thescreening visit.
12. Positive screening result for drugs of abuse or alcohol at the screening visit.
13. History of alcohol abuse or excessive intake of alcohol, as judged by theInvestigator.
14. Presence or history of drug abuse, as judged by the Investigator.
15. History of, or current use of anabolic steroids, as judged by the Investigator.
16. Excessive caffeine consumption defined by a daily intake of > 5 cups (1 cup =approximately 240 mL) of caffeine containing beverages, as judged by the Investigator.
17. Plasma donation within 1 month of screening or blood donation (or corresponding bloodloss) during the last 3 months prior to screening.
18. The Investigator considers the participant unlikely to comply with trial procedures,restrictions and requirements.