• To assess the relationship between the dose of RhuDex® administered and the plasma concentrations achieved following single and repeated doses under fed and/or fasted conditions and with/without administration of pantoprazole [ Time Frame: 24 -96h pharmakokinetic laboratory values ] [ Designated as safety issue: No ]
  

• To gain further safety and tolerability data of RhuDex® [ Time Frame: during treatment phase and 28 days afterwards ] [ Designated as safety issue: Yes ]
  

Drug: RhuDex®
• Treatment A.1: 31.65 mg RhuDex® once N=12
• Treatment A.2: 63.33 mg RhuDex® once N=12
• Treatment A.3: 126.63 mg RhuDex® once N=12
• Treatment A.4: 253.26 mg RhuDex® once N=12
• Treatment B.1: 31.65 mg RhuDex® once N=12
• Treatment B.2: selected dose of RhuDex® once N=12
• Treatment C: selected dose of RhuDex® once N=12
• Treatment D: selected dose of RhuDex® twice daily for 6 days N=12

This is an open-label, non-randomized, monocentric Phase I study to evaluate the pharmacokinetic profile of single-dosed and repeat-dosed RhuDex® using a tablet formulation as well as to assess the effect of food and the effect with co-administration of a proton pump inhibitor on the bioavailability of RhuDex®.

12 healthy male subjects will receive study medication in 8 different treatment periods in 4 subsequent steps A, B, C and D.

Within steps A and B, the subjects will receive different treatments (4 in A and 2 in B), sequentially. There will be a wash-out period of at least 4 days between each of the 8 different treatments/treatment periods of steps A, B, C and D.

In Step A, each subject will receive increasing doses of RhuDex® in 4 subsequent treatments. In Step B, each subject will receive 2 different doses of RhuDex® preceded by pantoprazole intake, in 2 subsequent treatments, and in Step C the RhuDex® dosing will be preceded by a standardized high-fat, high-calorie meal. In Step D, RhuDex® will be administered twice daily for 7 days.

For assessing the pharmacokinetic profile of RhuDex® in steps A, B and C, blood samples will be collected prior to and at different intervals after RhuDex® administration. In step D, blood samples will be collected on Days 1, 2, 4 and 7. Cmin, Cmax, tmax, t½ term, CL/F, AUC(0-t), and AUC(0-∞) of RhuDex® will be analyzed.

Safety will be evaluated by regular observation and documentation of AEs, vital signs, physical examination, ECG, and laboratory parameters.

Inclusion Criteria:

1. Healthy male subjects between 18 and 60 years at the time of enrolment
2. Subjects who are sexually active must use adequate contraception for the duration of the study from screening until 12 weeks after the last dose.
3. BMI between 18.5 and 29.9 kg/m²
4. Written informed consent
5. Ability to comply with the requirements of the study

Exclusion Criteria:

1. Acute infection at time of enrolment
2. History of chronic inflammation, chronic infection, other chronic disease, autoimmune disorders (e.g. diabetes mellitus) or cancer
3. Clinically significant abnormal ECG
4. Clinically significant abnormal laboratory values (especially in terms of liver or renal insufficiency)
5. Clinically significant physical findings
6. Major surgery within the last 4 weeks prior to enrolment
7. Organ allograft recipient
8. Concomitant or planned treatment which would interfere with study results
9. Any systemic medical treatment, including over the counter products and dietary supplements such as iodine, fluoride or vitamins, within one week before and during the study course
10. Known allergy against any ingredient of the study medication, meglumine, pantoprazole or bovine milk
11. Participation in an investigational trial within 12 weeks prior to enrolment
12. Systemic intake of immunosuppressive or immunomodulatory medication or vaccination within 30 days prior to enrolment and for the whole study duration
13. Blood loss exceeding 450 mL (including blood donations) within 12 weeks prior to enrolment into the study.
14. Medical history of alcohol or drug abuse within the last 2 years or alcohol consumption greater than 21 units per week.
15. A positive alcohol breath test
16. A positive urine drug screen
17. Smokers who smoke > 5 cigarettes or 5 cigars per day
18. Presence of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or HIV-1 or HIV-2 antibodies at screening
19. Subject whose partner is pregnant or lactating