Psoriasis
Conditions
Brief summary
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab
Detailed description
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)
Interventions
DRUGBrodalumab
Brodalumab is a large molecule for the treatment of inflammatory diseases
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. | 60 days | Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection |
| Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab | 60 days | Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 60 days | Presence of binding or neutralizing anti-brodalumab antibodies |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| (Treatment A Day 1-28 + Treatment B Day 29-56) 210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28) first, then followed by Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases | 73 |
| (Treatment B Days 1-28 + Treatment 8 Days 29-56) 210 mg SC Brodalumab (2 Pre-filled Syringes \[1.0mL + 0.5mL, Treatment B Days 1-28\]) first, then Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56)
Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases | 72 |
| Total | 145 |
Baseline characteristics
| Characteristic | (Treatment A Day 1-28 + Treatment B Day 29-56) | (Treatment B Days 1-28 + Treatment 8 Days 29-56) | Total |
|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 10.7 | 41.1 years STANDARD_DEVIATION 10.8 | 40.8 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 30 Participants | 24 Participants | 54 Participants |
| Sex: Female, Male Male | 43 Participants | 48 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 141 | 39 / 131 |
| serious Total, serious adverse events | 0 / 141 | 0 / 131 |
Outcome results
Primary
Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
Time frame: 60 days
Population: Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe) | Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab | 125 (day*mg/mL) | Standard Deviation 69 |
| Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL]) | Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab | 149 (day*mg/mL) | Standard Deviation 81.5 |
Primary
Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.
Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection
Time frame: 60 days
Population: Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe) | Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. | 13.8 milligrams per milliliter | Standard Deviation 7.85 |
| Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL]) | Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. | 14.8 milligrams per milliliter | Standard Deviation 7.7 |
Secondary
Immunogenicity
Presence of binding or neutralizing anti-brodalumab antibodies
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe) | Immunogenicity | 0 participants |
| Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL]) | Immunogenicity | 0 participants |