A Phase 1 interventional study of Tralokinumab administered as 1 × X mL with Device A and Tralokinumab administered as 2 × Y mL with Device B in Healthy, sponsored by LEO Pharma. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by LEO Pharma · Phase 1, Interventional, and Treatment
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).
LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: Tralokinumab administered as 1 × X mL with Device A · Device: Tralokinumab administered as 2 × Y mL with Device B
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)
Drug: Tralokinumab administered as 1 × X mL with Device A · Device: Tralokinumab administered as 2 × Y mL with Device B
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
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
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
Time frame: 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.
Time frame: 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
Time frame: In each Treatment Period pre-dose to 16 weeks post dose
Time corresponding to observed maximum serum concentration (tmax)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Day 1 to Day 239
Plan to share: No
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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LEO Pharma