Healthy Volunteers (arthritis, skin conditions, digestive disorders) anti inflammation biosimilar
Conditions
Interventions
On Day -1, subjects will be admitted to the study site and will remain resident
at the study site until Day 8 (after completion of the Day 8 assessments).
Subjects will be randomized on Day 1 and wi
phase 1
Sponsors
Merck
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of IMP in blood over time Maximum concentration of IMP in blood reached Concentration of IMP in blood over time until no longer detectable | — |
Secondary
| Measure | Time frame |
|---|---|
| - Various time-dependent PK measurements of IMP concentration in blood - Vital signs - Blood chemistry - Emergence of AEs and SAEs - Assessment of development of anti-drug and neutralising antibodies | — |
Countries
Poland
Outcome results
None listed