Healthy volunteers
Conditions
Interventions
Group 1: Group A: Healthy volunteers will be included into this double blind, placebo-controlled trial to receive a single intravenous dose of 0.5 mg/kg ATROSAB or placebo. Due to the occurrence of si
Sponsors
Baliopharm GmbH
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy male volunteers who agree to use appropriate contraception methoids; age 18-45 years
Exclusion criteria
Exclusion criteria: 1. Positive test for HIV antibodies, hepatitis B-virus surface antigen (HbsAg), anti-hepatitis-C virus antibodies (Anti-HCV) or no performed test. 2. Subjects with febrile or infectious illness within the last 7 days prior to administration of the IMP. 3. Subjects demonstrating any active physical disease, acute or chronic. 4. History of alcohol or drug abuse. 5. Subjects who have consumed ethanol within 48 hours prior to IMP administration. 6. More than moderate alcohol consumption (> 20 g of ethanol regularly per day or > 245 g regularly per week). 7. Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis abuse. 8. Heavy smoker (> 10 cigarettes per day) and unable to stop smoking during hospitalization 9. History of known hypersensitivity or allergy to monoclonal antibodies or excipients used in the formulation. 10. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day). 11. Consumption of xanthine-containing food or beverages as well as grapefruit juice within 48 hours prior to study drug administration. 12. Strictly vegetarians or vegans. 13. Any cardiovascular diseases or atrioventricular (AV) block (PQ time > 220 ms and/or QTcB > 450 ms at rest). 14. Antibiotic therapy for more than 7 days during the last 3 months. 15. Participation in any other clinical study or donation of more than 400 ml blood during the last 90 days before IMP administration. 16. History of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal (e.g., gastric and intestinal ulcer, cholecystectomy), neurological (especially history of epileptic seizures), endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency. 17. Unexplained weight loss or weight gain of more than 5 kg in the month prior to the study. 18. Subjects on a weight reduction program or a medically supervised diet. 19. Use of any medication (self-medication or prescription medication) within one week before IMP administration (or at least 10 times the respective elimination half-life, whichever is longer). 20. Subjects with latent TB (as diagnosed by Quantiferon test). 21. Subjects who have received an investigational drug and/or a vaccination within 3 months prior to start of the treatment in study and those who anticipate receipt of a vaccine within 2 months after administration of the study drug. 22. Subjects, who have received prior treatment within 1 year with monoclonal antibodies or other biologic agents. 23. Participation in this study on a previous dose level. 24. Subjects who are aware of having had contact to TBC (tuberculosis) patients within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of ATROSAB: evaluated via clinical laboratory parameters (before, 24, 48 hours, 17, 31, 45 and 59 days after drug administration. Vital parameters (blood pressure, pulse rate, body temperature: before, 5 minutes, 1, 4, 24, 48 hours, 4, 7, 31, 45 and 59 days after drug administration. ECG: before, 5 minutes, 24, 48 hours, 4, 17, 31, 45 and 59 days after drug administration. Documentation of adverse events: before, 5 minutes, 1, 4, 24, 48 hours, 4, 17, 31, 45 and 59 days after drug administration. Local tolerability: before, 5 minutes, 1, 4, 24 and 48 hours after drug administration. Pharmacokinetics of ATROSAB: Blood samples for the determination of pharmacokinetic parameters are drawn at the following time points: before, 5 minutes, 1, 2, 4, 8, 12, 24, 48 hours, 4, 17, 31, 45 and 59 days after drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics (anti-inflammatory effects): Anti-inflammatory effects are investigated by means of an ex-vivo assay; therefore blood samples will be stimulated ex vivo with tumor necrosis factor and the release of cytokines will be tested in the assay. These tests will be performed before, 5 minutes, 12, 24, 48 hours, 4, 17, 31, 45 and 59 days after drug administration. | — |
Countries
Germany
Contacts
Public ContactGrit Andersen
Focus Clinical Drug Development GmbH
Outcome results
None listed