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To compare bioavailability and pharmacokinetics of CAT-354 following subcutaneous administration compared with intravenous administration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAT-354 150 mg (intravenous) | Experimental | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
|
| CAT-354 150 mg (subcutaneous) | Experimental | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
|
| CAT-354 300 mg (subcutaneous) | Experimental | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAT-354 150 mg (intravenous) | Biological | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MedImmune LLC | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services (US) Inc. | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20565456 | Background | Oh CK, Faggioni R, Jin F, Roskos LK, Wang B, Birrell C, Wilson R, Molfino NA. An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males. Br J Clin Pharmacol. 2010 Jun;69(6):645-55. doi: 10.1111/j.1365-2125.2010.03647.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CAT-354 150 mg (Intravenous) | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| FG001 | CAT-354 150 mg (Subcutaneous) | A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. |
| FG002 | CAT-354 300 mg (Subcutaneous) | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CAT-354 150 mg (Intravenous) | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
| BG001 | CAT-354 150 mg (Subcutaneous) | A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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). | Posted | Geometric Mean | 90% Confidence Interval | percent bioavailability | 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 |
|
Day 0 to 56
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAT-354 150 mg (Intravenous) | A single dose of CAT-354 150 milligram (mg) intravenous infusion over 30 minutes on Day 0. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | MedDRA 11.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meena Jain, MB BChir/Associate Medical Director | MedImmune, LLC | 301-398-0000 | jainm@medimmune.com |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C574065 | tralokinumab |
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| CAT-354 150 mg (subcutaneous) | Biological | A single dose of CAT-354 150 mg injection subcutaneously on Day 0. |
|
|
| CAT-354 300 mg (subcutaneous) | Biological | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
|
|
| Day 0 to 56 |
| 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]) | 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). | 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 |
| 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) | 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. | 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 |
| 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 |
| 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 |
| 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) | Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half. | 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 |
| 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). | 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 |
| 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. | 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 |
| 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). | 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 |
| BG002 | CAT-354 300 mg (Subcutaneous) | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| CAT-354 150 mg (Subcutaneous) |
A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. |
| OG001 | CAT-354 300 mg (Subcutaneous) | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. |
|
|
| 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. | Safety population included all participants randomized to treatment, and received at least 1 dose of study medication. | Posted | Number | participants | Day 0 to 56 |
|
|
|
| Secondary | Number of Participants Exhibiting Anti-Drug Antibodies for CAT-354 at Any Visit | Safety population included all participants randomized to treatment, and received at least 1 dose of study medication. | Posted | Number | participants | Day 0 and Day 56 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | (microgram*day)/milliliter (mcg*day/mL) | 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 |
|
|
|
| Secondary | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - 56]) | 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. | Posted | Mean | Standard Deviation | mcg*day/mL | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | ([mcg*day]/mL)/mg | 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 |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) | 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. | Posted | Mean | Standard Deviation | microgram/milliliter (mcg/mL) | 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 |
|
|
|
| Secondary | Dose Normalized Maximum Observed Concentration (Cmax/Dose) | 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. | Posted | Mean | Standard Deviation | (mcg/mL)/mg | 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 |
|
|
|
| Secondary | Time to Reach Maximum Observed Serum Concentration (Tmax) | 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. | Posted | Median | Full Range | days | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | days | 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 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | mL/day | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/day | 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 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | mL | 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 |
|
|
|
| 0 |
| 10 |
| 5 |
| 10 |
| EG001 | CAT-354 150 mg (Subcutaneous) | A single dose of CAT-354 150 mg injection, subcutaneously on Day 0. | 0 | 10 | 5 | 10 |
| EG002 | CAT-354 300 mg (Subcutaneous) | A single dose of CAT-354 300 mg injection subcutaneously on Day 0. | 0 | 10 | 4 | 10 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paranasal sinus hype | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pharyngolaryngeal pa | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|