Phase 1
Completed N=145
A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Source: ClinicalTrials.gov NCT02173392 ↗Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. — 13.8; 14.8 milligrams per milliliter
Summary
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. |
13.8; 14.8 | — |
| PRIMARY Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab |
125; 149 | — |
| SECONDARY Immunogenicity |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females must be of non-reproductive potential
Exclusion Criteria
- no history or evidence of clinically significant disorder that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
Data sourced from ClinicalTrials.gov (NCT02173392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.