The primary objective is to investigate and compare the pharmacokinetic (PK) of MSB11022 acetate versus MSB11022-citrate in healthy subjects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Healthy Volunteers (arthritis, skin conditions, digestive disorders)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
MSB11022 is a proposed biosimilar to adalimumab (Humira®). To establish
biosimilarity, the candidate biosimilar compound must be similar to the
reference product, notwithstanding minor differences in clinically inactive
components, and there must be no clinically meaningful differences between the
biological product and the reference product in terms of the safety, purity,
and potency of the product (Food and Drug Administration [FDA] Guidance for
Industry. Scientific Considerations in Demonstrating Biosimilarity to a
Reference Product 2015) Development of a biosimilar generally includes a
comparison of the proposed product and the reference product with respect to
structure, function, human pharmacokinetic (PK), clinical immunogenicity, and
clinical safety and effectiveness.
Study objective
The primary objective is to investigate and compare the pharmacokinetic (PK) of
MSB11022 acetate versus MSB11022-citrate in healthy subjects.
Study design
This is a Phase I, randomized, double-blind, 2 arm, parallel group, single-dose
study. The study will evaluate the PK, safety, tolerability, and immunogenicity
of 2 formulations of MSB11022: MSB11022-acetate versus MSB11022 citrate.
Intervention
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 will receive a single 40 mg dose of
MSB11022-acetate or MSB11022-citrate administered by subcutaneous injection in
the lower abdomen (at least 2 inches (5 cm) from the umbilicus). Blood samples
for PK analysis will be collected predose (0 hour) and at scheduled time points
up to Day 71 postdose. Subjects will be monitored for safety up to Day 71
postdose.
Study burden and risks
In the Phase I EMR200588-001 study, PK equivalence between the MSB11022-citrate
formulation, US-RP, and EU-RMP was demonstrated. Safety, tolerability, and
immunogenicity profiles were similar between subjects receiving MSB11022 and
US-RP or EU RMP. These results establish the PK element of the scientific
bridge between all 3 products to justify the relevance of data obtained using
EU RMP to support a demonstration of biosimilarity to US-RP.
The purpose of this Phase I clinical study is to compare the PK, safety,
immunogenicity, and tolerability of the MSB11022-acetate formulation versus the
MSB11022-citrate formulation, both administered by prefilled syringe (PFS) in
healthy subjects.
Frankfurter Str. 250
Darmstadt D-64293
DE
Frankfurter Str. 250
Darmstadt D-64293
DE
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003263-19-NL |
| CCMO | NL58991.056.16 |