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This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab-TUR01 | Experimental |
| |
| Adalimumab-EU | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TUR01 | Biological | Administered as a single 40 mg, subcutaneous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to infinity (AUCinf) | AUCinf = area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) + last observed concentration (Ct)/terminal rate constant (λz) | Day 1 - Day 71 |
| Maximum serum concentration (Cmax) | Cmax | Day 1 - Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) | Day 1 - Day 71 | |
| Area under the concentration-time curve from time zero to 336 hours (AUC336) | Area under the concentration-time curve from time zero to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity - Incidence of anti-drug antibodies to adalimumab | Day 1 - Day 71 | |
| Immunogenicity - Incidence of neutralizing antibodies | Day 1 - Day 71 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainard Fuhr | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International GmbH, Early Phase Clinical Unit Berlin | Berlin | 14050 | Germany |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Adalimumab-EU | Biological | Administered as a single 40 mg, subcutaneous dose |
|
|
| Day 1 - Day 15 |
| Area under the concentration-time curve from time zero to 672 hours (AUC672) | Area under the concentration-time curve from time zero to 28 days | Day 1 - Day 29 |
| Area under the concentration-time curve from time zero to 1008 hours (AUC1008) | Area under the concentration-time curve from time zero to 42 days | Day 1 - Day 43 |
| Area under the concentration-time curve from time zero to 1680 hours (AUC1680) | Area under the concentration-time curve from time zero to 70 days | Day 1 - Day 71 |
| Time to Cmax (Tmax) | Time to reach the maximum concentration | Day 1 - Day 71 |
| Apparent volume of distribution based on the terminal phase (Vz/F) | Day 1 - Day 71 |
| Terminal rate constant (λz) | The parameter will be calculated by linear least squares regression analysis using at least 3 non-zero concentrations in the terminal phase | Day 1 - Day 71 |
| Terminal half-life calculated by ln(2)/λz (t½) | Day 1 - Day 71 |
| Apparent total body clearance (CL/F) | Day 1 - Day 71 |
| Area under the concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap) | Day 1 - Day 71 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |