Asthma, Healthy
Conditions
Keywords
Asthma, CAT-354, Tralokinumab, Healthy
Brief summary
To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.
Detailed description
To compare the bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration of 150 milligram (mg) and 300 mg compared with 150 mg given intravenously.
Interventions
BIOLOGICALCAT-354 150 mg (intravenous)
A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0.
BIOLOGICALCAT-354 150 mg (subcutaneous)
A single dose of CAT-354 150 mg injection subcutaneously on Day 0.
BIOLOGICALCAT-354 300 mg (subcutaneous)
A single dose of CAT-354 300 mg injection subcutaneously on Day 0.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed and dated written informed consent is obtained prior to any study related procedure taking place * Males, aged 19-55 years * No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history) * A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities) * Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator * A negative screen for drugs of abuse and alcohol * Body mass index (BMI) between 18-30 kilogram per square meter (kg/m\^2), inclusive * No other clinically significant abnormality on history and clinical examination * Able to comply with the requirements of the protocol.
Exclusion criteria
* Any active concomitant disease including psychological disorders * History of medication that might carry over effects into study * Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354 * Participation in another investigational medicinal product study within 3 months of the start of this study or 5 half-lives of the previously administered investigational medicinal product (IMP), whichever is the longer except methodological studies in which no IMP was given * Any acute illness in the 2 weeks before Day 0 (Visit 2) * Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation * Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first degree relative of the aforementioned * Any factor which, in the opinion of the Investigator, would jeopardize the evaluation or safety or be associated with poor adherence to the protocol * The subject's primary care physician recommends the subject should not take part in the study * Subjects with immunodeficiency disorders * Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Bioavailability of CAT-354 After Subcutaneous Dose | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit | Day 0 and Day 56 | — |
| Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity]) | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). |
| Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56]) | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | — |
| Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose) | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC \[0 - infinity\]) was normalized by CAT-354 dose. |
| Maximum Observed Serum Concentration (Cmax) | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | — |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 0 to 56 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state. |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | — |
| Terminal Phase Elimination Half Life (t1/2) | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half. |
| Apparent Systemic Clearance (CL/F) After Subcutaneous Dose | Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability). |
| Apparent Systemic Clearance (CL/F) After Intravenous Dose | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
| Volume of Distribution at Steady State (Vss) After Intravenous Infusion | Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)\*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM\[Infinity\] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity). |
| Dose Normalized Maximum Observed Concentration (Cmax/Dose) | Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CAT-354 150 mg (Intravenous) A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. | 10 |
| CAT-354 150 mg (Subcutaneous) A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. | 10 |
| CAT-354 300 mg (Subcutaneous) A single dose of CAT-354 300 mg injection subcutaneously on Day 0. | 10 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | CAT-354 150 mg (Intravenous) | CAT-354 150 mg (Subcutaneous) | CAT-354 300 mg (Subcutaneous) | Total |
|---|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 8.3 | 39.3 years STANDARD_DEVIATION 8.6 | 27.8 years STANDARD_DEVIATION 10.4 | 32.5 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 10 | 5 / 10 | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Absolute Bioavailability of CAT-354 After Subcutaneous Dose
Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was assessed by the geometric least-square means ratios of subcutaneous to intravenous dose-normalized area under the serum concentration-time curve from time zero to infinity (AUC \[0 - infinity\]/Dose). AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: Pharmacokinetic (PK) population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate maximum observed serum concentration (Cmax).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Absolute Bioavailability of CAT-354 After Subcutaneous Dose | 62.1 percent bioavailability |
| CAT-354 300 mg (Subcutaneous) | Absolute Bioavailability of CAT-354 After Subcutaneous Dose | 60.1 percent bioavailability |
Secondary
Apparent Systemic Clearance (CL/F) After Intravenous Dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Apparent Systemic Clearance (CL/F) After Intravenous Dose | 188 mL/day | Standard Deviation 84 |
Secondary
Apparent Systemic Clearance (CL/F) After Subcutaneous Dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).
Time frame: Predose, 30 minutes, at 1, 3, 8 and 24 hours post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Apparent Systemic Clearance (CL/F) After Subcutaneous Dose | 292 mL/day | Standard Deviation 82.3 |
| CAT-354 300 mg (Subcutaneous) | Apparent Systemic Clearance (CL/F) After Subcutaneous Dose | 307 mL/day | Standard Deviation 109 |
Secondary
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity])
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity]) | 903 (microgram*day)/milliliter (mcg*day/mL) | Standard Deviation 291 |
| CAT-354 300 mg (Subcutaneous) | Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity]) | 548 (microgram*day)/milliliter (mcg*day/mL) | Standard Deviation 143 |
| CAT-354 300 mg (Subcutaneous) | Area Under the Concentration-time Curve From Zero to Infinity (AUC [0 - Infinity]) | 1080 (microgram*day)/milliliter (mcg*day/mL) | Standard Deviation 315 |
Secondary
Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56])
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56]) | 765 mcg*day/mL | Standard Deviation 220 |
| CAT-354 300 mg (Subcutaneous) | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56]) | 467 mcg*day/mL | Standard Deviation 122 |
| CAT-354 300 mg (Subcutaneous) | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56]) | 881 mcg*day/mL | Standard Deviation 287 |
Secondary
Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose)
AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). (AUC \[0 - infinity\]) was normalized by CAT-354 dose.
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose) | 6.02 ([mcg*day]/mL)/mg | Standard Deviation 1.94 |
| CAT-354 300 mg (Subcutaneous) | Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose) | 3.66 ([mcg*day]/mL)/mg | Standard Deviation 0.953 |
| CAT-354 300 mg (Subcutaneous) | Dose Normalized Area Under the Concentration-time Curve From Zero to Infinity ([AUC {0 - Infinity}]/Dose) | 3.59 ([mcg*day]/mL)/mg | Standard Deviation 1.05 |
Secondary
Dose Normalized Maximum Observed Concentration (Cmax/Dose)
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Dose Normalized Maximum Observed Concentration (Cmax/Dose) | 0.389 (mcg/mL)/mg | Standard Deviation 0.096 |
| CAT-354 300 mg (Subcutaneous) | Dose Normalized Maximum Observed Concentration (Cmax/Dose) | 0.114 (mcg/mL)/mg | Standard Deviation 0.039 |
| CAT-354 300 mg (Subcutaneous) | Dose Normalized Maximum Observed Concentration (Cmax/Dose) | 0.122 (mcg/mL)/mg | Standard Deviation 0.044 |
Secondary
Maximum Observed Serum Concentration (Cmax)
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Maximum Observed Serum Concentration (Cmax) | 58.3 microgram/milliliter (mcg/mL) | Standard Deviation 14.4 |
| CAT-354 300 mg (Subcutaneous) | Maximum Observed Serum Concentration (Cmax) | 17.1 microgram/milliliter (mcg/mL) | Standard Deviation 5.91 |
| CAT-354 300 mg (Subcutaneous) | Maximum Observed Serum Concentration (Cmax) | 36.6 microgram/milliliter (mcg/mL) | Standard Deviation 13.1 |
Secondary
Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit
Time frame: Day 0 and Day 56
Population: Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit | 0 participants |
| CAT-354 300 mg (Subcutaneous) | Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit | 0 participants |
| CAT-354 300 mg (Subcutaneous) | Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit | 0 participants |
Secondary
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 56 that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Day 0 to 56
Population: Safety population included all participants randomized to treatment, and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 5 participants |
| CAT-354 150 mg (Subcutaneous) | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| CAT-354 300 mg (Subcutaneous) | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 5 participants |
| CAT-354 300 mg (Subcutaneous) | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| CAT-354 300 mg (Subcutaneous) | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 4 participants |
| CAT-354 300 mg (Subcutaneous) | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
Secondary
Terminal Phase Elimination Half Life (t1/2)
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Terminal Phase Elimination Half Life (t1/2) | 21.4 days | Standard Deviation 2.46 |
| CAT-354 300 mg (Subcutaneous) | Terminal Phase Elimination Half Life (t1/2) | 19.2 days | Standard Deviation 3.1 |
| CAT-354 300 mg (Subcutaneous) | Terminal Phase Elimination Half Life (t1/2) | 19.4 days | Standard Deviation 3.59 |
Secondary
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: Predose, end of infusion, 30 minutes, 1, 3, 8 and 24 hours post-end of infusion/post-injection on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 0.063 days |
| CAT-354 300 mg (Subcutaneous) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 5 days |
| CAT-354 300 mg (Subcutaneous) | Time to Reach Maximum Observed Serum Concentration (Tmax) | 5 days |
Secondary
Volume of Distribution at Steady State (Vss) After Intravenous Infusion
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution at steady state (Vss) after intravenous dosing was estimated by the formula Vss=MRT(Infinity)\*CL, where MRT(Infinity)= AUCM(Infinity)/AUC(0 - infinity) where MRT(Infinity) = mean residence time at infinity, CL= clearance, AUCM\[Infinity\] = area under the moment curve, and AUC (0 - infinity) = area under the serum concentration versus time curve from time zero (predose) to extrapolated infinite time (0 - infinity).
Time frame: Predose, end of infusion, 30 minutes, at 1, 3, 8 and 24 hours post-end of infusion on Day 0; Day 3, 5, 7, 9, 14, 21, 28, 35, 42 and 56
Population: PK population included all evaluable participants who received at least 1 dose of study medication and had sufficient post-dose blood samples to estimate Cmax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAT-354 150 mg (Subcutaneous) | Volume of Distribution at Steady State (Vss) After Intravenous Infusion | 4960 mL | Standard Deviation 1440 |