A Phase I, Randomized, Double-Blind, Parallel Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Two Formulations of MSB11022 (Proposed Adalimumab Biosimilar)<br>
- Conditions
- Healthy Volunteers (arthritis, skin conditions, digestive disorders)anti inflammationbiosimilar
- Registration Number
- NL-OMON43181
- Lead Sponsor
- Merck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Healthy male and female subjects, 18 to 55 years of age, who are on adequate contraception and are willing and able to comply with the scheduled study visits, investigational medicinal product administration, laboratory tests, and all other study procedures will be eligible for participation in the study.
Other protocol-defined inclusion criteria could apply.
- A history and/or current presence of clinically significant atopic allergy, hypersensitivity or allergic reactions
- Having active or latent tuberculosis or a history of tuberculosis
- Having a lifetime history of invasive systemic fungal infections or other opportunistic infections, chronic or recurrent infections
- Having previously been treated with adalimumab or taken a recombinant monoclonal antibody, or having received a live vaccine within 12 weeks before enrolling in this study or planning for any such
vaccination during the study or within 4 months after study drug administration.
Other protocol-defined exclusion criteria could apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Concentration of IMP in blood over time<br /><br>Maximum concentration of IMP in blood reached<br /><br>Concentration of IMP in blood over time until no longer detectable</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Various time-dependent PK measurements of IMP concentration in blood<br /><br>- Vital signs<br /><br>- Blood chemistry<br /><br>- Emergence of AEs and SAEs<br /><br>- Assessment of development of anti-drug and neutralising antibodies</p><br>