Clinical Phase I study to assess safety tolerability, pharmacokinetics and pharmacodynamics of ATROSAB (Anti-TNF-receptor 1 monoclonal antibody) in response to single ascending intravenous infusion doses. A single center, randomized, double blind, parallel group and placebo-controlled clinical trial in healthy male subjects

Phase 1

• Conditions: Healthy volunteers

• Registration Number: DRKS00004400
• Lead Sponsor: Baliopharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-04
• Study Completion: 2014-07-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

Healthy male volunteers who agree to use appropriate contraception methoids; age 18-45 years

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified