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The purpose of this trial is to compare the pharmacokinetics (PK), safety, tolerability and immunogenicity of a single dose of 300 mg tralokinumab administered as a 1 × X mL subcutaneous (SC) injection with Device A and 2 × Y mL consecutive SC injections with Device B.
This is a single center, randomized, open label, 2 period, 2 sequence cross over trial designed to compare the PK and to evaluate the safety, tolerability and immunogenicity of 300 mg tralokinumab administered as a 1 × X mL SC injection with Device A (test treatment [T]) and 2 × Y mL consecutive SC injections with Device B (reference treatment [R]) in healthy subjects. Additionally, the experience of tralokinumab being administered with Device A compared to Device B will be evaluated.
After being informed about the study and the potential risks, all subjects giving written informed consent will be enrolled and randomized to 1 of 2 treatment sequences, Sequence TR or Sequence RT in a 1:1 ratio (i.e., subjects receive the 2 treatments in the specified order).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR (Test-Reference) | Experimental | Treatment period 1: 300 mg tralokinumab, single subcutaneous dose, 1 × X mL Device A (Test treatment, T) Treatment period 2: 300 mg tralokinumab, subcutaneous dose, 2 × Y mL Device B (Reference treatment, R) |
|
| RT (Reference-Test) | Experimental | Treatment period 1: 300 mg tralokinumab, subcutaneous dose, 2 × Y mL Device B (Reference treatment, R) Treatment period 2: 300 mg tralokinumab, single subcutaneous dose, 1 × X mL Device A (Test treatment, T) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tralokinumab administered as 1 × X mL with Device A | Drug | Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serum concentration time curve from time 0 (pre dose) extrapolated to infinity (AUC0-inf) in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose | In each Treatment Period pre-dose to 16 weeks post dose | |
| Area under the serum concentration time curve from time 0 (pre dose) to time of last quantifiable concentration in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose. | In each Treatment Period pre-dose to 16 weeks post dose | |
| Observed maximum serum concentration (Cmax) in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose | In each Treatment Period pre-dose to 16 weeks post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time corresponding to observed maximum serum concentration (tmax) | In each Treatment Period pre-dose to 16 weeks post dose | |
| Terminal half life (t½) in each Treatment Period derived from all observed concentrations in the time period pre dose to 16 weeks post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LEO Pharma Investigational Site | Berlin | 14050 | Germany |
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| Tralokinumab administered as 2 × Y mL with Device B | Device | Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration |
|
| In each Treatment Period pre-dose to 16 weeks post dose |
| Apparent total body clearance (CL/F), calculated as dose/AUC0-inf | (AUC0-inf: Area under the serum concentration time curve from time 0 (pre dose) extrapolated to infinity) | In each Treatment Period pre-dose to 16 weeks post dose |
| Apparent volume of distribution based on terminal phase (Vz/F), calculated as t½/ln(2)*CL/F | (t½: Terminal half life; CL/F: Apparent total body clearance) | In each Treatment Period pre-dose to 16 weeks post dose |
| Number of treatment emergent adverse events (TEAEs) from Day 1 to Day 126 and of TEAEs from Day 127 to Day 239 (number of adverse events [AEs] emerging with each treatment) | Day 1 to Day 239 |
| Presence of binding and neutralizing anti-drug antibodies (ADAs) at Days 1 (pre dose), 15, and 57 of Treatment Periods 1 and 2 and Day 239 | Day 1 to Day 239 |