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The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
This is a Phase 1, open-label, assessor-blind, parallel-group study to evaluate the PK and tolerability of a single subcutaneous dose of 300 milligram (mg) tralokinumab when delivered as a 2 milliliters (mL) injection at different flow rates to healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'W' mL/min. |
|
| Cohort 2 | Experimental | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'X' mL/min. |
|
| Cohort 3 | Experimental | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Y' mL/min. |
|
| Cohort 4 | Experimental | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 'Z' mL/min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tralokinumab 300 mg | Biological | Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day*micrograms per millilitres = day*mcg/mL. | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
| Maximum Observed Serum Concentration (Cmax) | The Cmax is the maximum observed serum concentration of tralokinumab. | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
| Time to Maximum Concentration (Tmax) | Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration. | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
| Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) | AUC [0-t] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration. | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
| Terminal Elimination Half-life (t1/2) | Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Local Injection-Site Pain and Injection-Site Pruritus | Local injection-site pain and pruritus intensity was rated on 0 to 100 millimeter (mm) visual analogue scale (VAS) at various time points, where 0 = no pain/ no pruritus; 100 = most severe pain/ most severe pruritus. Injection site pruritus intensity was assessed by the blinded assessor. Higher the score indicated higher intensity of pain and pruritus. Local injection site pain and pruritus was assessed at below time-points: 1 and 6 minute (min) during investigational product administration (IPA); immediately post IPA, 10, 20, 30, and 60 min, 2, 4, 8, 24 and 72 hour (h) post IPA. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Cook, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28590244 | Background | Jain M, Doughty D, Clawson C, Li X, White N, Agoram B, van der Merwe R. Tralokinumab pharmacokinetics and tolerability when administered by different subcutaneous injection methods and rates . Int J Clin Pharmacol Ther. 2017 Jul;55(7):606-620. doi: 10.5414/CP203023. |
| Label | URL |
|---|---|
| Redacted Protocol | View source |
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A total of 149 participants were screened for the study, out of which 60 participants were randomized and completed in the study.
This study was conducted between 19Mar2014 and 10Jul2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min. |
| FG001 | Cohort 2 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min. |
| FG002 | Cohort 3 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min. |
| FG003 | Cohort 4 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As-treated population included all participants who were randomized and received any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min. |
| BG001 | Cohort 2 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min. |
| 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 | 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 to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day*micrograms per millilitres = day*mcg/mL. | The Pharmacokinetic (PK) population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
|
Day 1 to Day 57
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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 | Cohort 1 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 6 mL/min. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meena Jain | MedImmune, LLC | +44 (0) 1223 895966 | jainm@medimmune.com |
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| 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 |
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|
| 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). | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
| Apparent Terminal-Phase Volume of Distribution (Vz/F) | 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. | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
| During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus |
| Number of Participants Reporting Local Injection-Site Reactions | The signs and/or symptoms of local injection-site reactions including erythema, hematoma or bleeding, local warmth, swelling, and/or rash occurring within 72 hours post-injection were assessed and recorded by a blinded assessor. | 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection |
| 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 and important medical event. Treatment-emergent were events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | From start of study drug administration up to Day 57 |
| Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination | The treatment-emergent adverse events related to physical examination were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | Day 1 to Day 57 |
| Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs | Vital signs included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature. The treatment-emergent adverse events related to vital signs were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | Day 1 to Day 57 |
| Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters | Laboratory parameters included hematology, serum chemistry and urinalysis. The treatment-emergent adverse events in laboratory parameters were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | Day 1 to Day 57 |
| Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit | Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. | Pre-dose on Day 1 and Day 57 |
| Lincoln |
| Nebraska |
| 68502 |
| United States |
| BG002 | Cohort 3 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min. |
| BG003 | Cohort 4 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Cohort 2 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min. |
| OG002 | Cohort 3 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min. |
| OG003 | Cohort 4 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min. |
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) | The Cmax is the maximum observed serum concentration of tralokinumab. | The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
|
|
|
| Primary | Time to Maximum Concentration (Tmax) | Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration. | The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure. | Posted | Median | Full Range | day | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
|
|
|
| Primary | Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) | AUC [0-t] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration. | The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*mcg/mL | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
|
|
|
| Primary | Terminal Elimination Half-life (t1/2) | Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | day | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
|
|
|
| Primary | 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). | The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters per day (mL/day) | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
|
|
|
| Primary | Apparent Terminal-Phase Volume of Distribution (Vz/F) | 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. | The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here "N" signifies participants who were evaluable for this measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliters (mL) | Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose |
|
|
|
| Secondary | Local Injection-Site Pain and Injection-Site Pruritus | Local injection-site pain and pruritus intensity was rated on 0 to 100 millimeter (mm) visual analogue scale (VAS) at various time points, where 0 = no pain/ no pruritus; 100 = most severe pain/ most severe pruritus. Injection site pruritus intensity was assessed by the blinded assessor. Higher the score indicated higher intensity of pain and pruritus. Local injection site pain and pruritus was assessed at below time-points: 1 and 6 minute (min) during investigational product administration (IPA); immediately post IPA, 10, 20, 30, and 60 min, 2, 4, 8, 24 and 72 hour (h) post IPA. | As-treated population included all participants who were randomized and received any study drug. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Mean | Standard Deviation | millimole (mmol) | During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus |
|
|
|
| Secondary | Number of Participants Reporting Local Injection-Site Reactions | The signs and/or symptoms of local injection-site reactions including erythema, hematoma or bleeding, local warmth, swelling, and/or rash occurring within 72 hours post-injection were assessed and recorded by a blinded assessor. | As-treated population included all participants who were randomized and received any study drug. | Posted | Count of Participants | Participants | 0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection |
|
|
|
| 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 and important medical event. Treatment-emergent were events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | As-treated population included all participants who were randomized and received any study drug. | Posted | Count of Participants | Participants | From start of study drug administration up to Day 57 |
|
|
|
| Secondary | Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination | The treatment-emergent adverse events related to physical examination were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | As-treated population included all participants who were randomized and received any study drug. | Posted | Count of Participants | Participants | Day 1 to Day 57 |
|
|
|
| Secondary | Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs | Vital signs included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature. The treatment-emergent adverse events related to vital signs were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | As-treated population included all participants who were randomized and received any study drug. | Posted | Count of Participants | Participants | Day 1 to Day 57 |
|
|
|
| Secondary | Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters | Laboratory parameters included hematology, serum chemistry and urinalysis. The treatment-emergent adverse events in laboratory parameters were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. | As-treated population included all participants who were randomized and received any study drug. | Posted | Count of Participants | Participants | Day 1 to Day 57 |
|
|
|
| Secondary | Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit | Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. | As-treated population included all participants who were randomized and received any study drug. | Posted | Count of Participants | Participants | Pre-dose on Day 1 and Day 57 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | Cohort 2 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 12 mL/min. | 0 | 15 | 0 | 15 | 5 | 15 |
| EG002 | Cohort 3 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 2 mL/min. | 0 | 15 | 0 | 15 | 4 | 15 |
| EG003 | Cohort 4 | Participants received 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at a flow rate of 0.167 mL/min. | 0 | 15 | 0 | 15 | 4 | 15 |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | 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. The PIs also agree for data to be presented first as a joint, multi-center publication.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
|
| Pain:6 min during IPA |
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| Pain: Immediately Post IPA |
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| Pain:10 min Post IPA |
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| Pain:20 min Post IPA |
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| Pain:30 min Post IPA |
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| Pain:60 min Post IPA |
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| Pain:2h Post IPA |
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| Pain:4h Post IPA |
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| Pain:8h Post IPA |
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| Pain:24h Post IPA |
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| Pain:72h Post IPA |
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| Pruritus:Immediately Post IPA |
|
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| Pruritus:10 min Post IPA |
|
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| Pruritus:20 min Post IPA |
|
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| Pruritus:30 min Post IPA |
|
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| Pruritus:60 min Post IPA |
|
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| Pruritus:2h Post IPA |
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| Pruritus:4h Post IPA |
|
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| Pruritus:8h Post IPA |
|
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| Pruritus:24h Post IPA |
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| Pruritus:72h Post IPA |
|
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| Hematoma or bleeding |
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| Local warmth |
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| Swelling |
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| Rash |
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| Other |
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| TESAEs |
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| Serum Chemistry |
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| Urinalysis |
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