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This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects
This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | single dose of MEDI9314 or placebo |
|
| Cohort 2 | Experimental | single dose of MEDI9314 or placebo |
|
| Cohort 3 | Experimental | single dose of MEDI9314 or placebo |
|
| Cohort 4 | Experimental | single dose of MEDI9314 or placebo |
|
| Japanese Cohort | Experimental | single dose of MEDI9314 or placebo |
|
| Cohort 5 | Experimental | single dose of MEDI9314 or placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI9314 | Drug | single dose of MEDI9314 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240. | From the start of study drug administration upto Day 240 |
| Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs | TEAEs observed in participants with clinically significant ECG abnormalities were reported. | From the start of study drug administration upto Day 240 |
| Number of Participants With Vital Signs Abnormalities Reported as TEAEs | Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported. | From the start of study drug administration upto Day 240 |
| Number of Participants With Physical Examination Abnormalities Reported as TEAEs | Adverse events observed in participants with clinically significant physical abnormalities were assessed. | From the start of study drug administration upto Day 240 |
| Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314 | The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314. | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muna Albayaty, MBChB, FFPM | Parexel | Principal Investigator |
| Hakop Gevorkyan, MD | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States | ||
| Research Site |
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A total of 124 participants were enrolled in the study; of which 80 participants were screen failures. Forty-four participants were randomized to MEDI9314 or placebo" in 7 treatment groups.
The study was conducted from 18Feb2016 to 12Jun2017 in United States and United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. |
| FG001 | Cohort 1 | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. |
| FG002 | Cohort 2 | Participants received a single SC injection of MEDI9314 150 mg on Day 1. |
| FG003 | Cohort 3 | Participants received a single SC injection of MEDI9314 300 mg on Day 1. |
| FG004 | Cohort 4 | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 |
| FG005 | Cohort 5 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. |
| FG006 | Cohort 6 | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The As-treated population included participants who received any study drug and summarized according to the treatment they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. |
| BG001 | Cohort 1 |
| 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240. | As-treated population included participants who received any study drug and summarized according to the treatment they actually received. | Posted | Count of Participants | Participants | From the start of study drug administration upto Day 240 |
From the start of study drug administration upto Day 240
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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 | Placebo | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rene van der Merwe | MedImmune | +44 (0)1223 898263 | information.center@astrazeneca.com |
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| placebo | Drug | single dose of placebo |
|
An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed. |
| From the start of study drug administration upto Day 240 |
| Number of Participants With TEAEs Related to Injection Site Reactions | Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed. | From the start of study drug administration upto Day 240 |
| Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast) | The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314. | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
| Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314 | The maximum observed serum drug concentration of MEDI9314. | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
| Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314 | The time to maximum observed serum drug concentration of MEDI9314. | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
| Terminal Phase Elimination Half-life (t1/2) of MEDI9314 | Terminal phase elimination half-life of MEDI9314 | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
| Serum Concentrations of MEDI9314 | Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed. | Baseline (Day 1 [predose]) and Day 240 |
| Number of Participants Positive for Anti-Drug Antibodies to MEDI9314 | Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented. | Baseline (Day 1 [predose]) and Day 240 |
| Harrow |
| HA1 3UJ |
| United Kingdom |
Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1.
| BG002 | Cohort 2 | Participants received a single SC injection of MEDI9314 150 mg on Day 1. |
| BG003 | Cohort 3 | Participants received a single SC injection of MEDI9314 300 mg on Day 1. |
| BG004 | Cohort 4 | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 |
| BG005 | Cohort 5 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. |
| BG006 | Cohort 6 | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
| BG007 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Placebo | Participants received a single subcutaneous (SC) or intravenous (IV) (infused using a syringe infusion pump over 60 to 90 minutes) dose of placebo matched to MEDI9314 on Day 1. |
| OG001 | Cohort 1 | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. |
| OG002 | Cohort 2 | Participants received a single SC injection of MEDI9314 150 mg on Day 1. |
| OG003 | Cohort 3 | Participants received a single SC injection of MEDI9314 300 mg on Day 1. |
| OG004 | Cohort 4 | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 |
| OG005 | Cohort 5 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. |
| OG006 | Cohort 6 | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. |
|
|
| Primary | Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs | TEAEs observed in participants with clinically significant ECG abnormalities were reported. | As-treated population included participants who received any study drug and summarized according to the treatment they actually received. | Posted | Count of Participants | Participants | From the start of study drug administration upto Day 240 |
|
|
|
| Primary | Number of Participants With Vital Signs Abnormalities Reported as TEAEs | Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported. | As-treated population included participants who received any study drug and summarized according to the treatment they actually received. | Posted | Count of Participants | Participants | From the start of study drug administration upto Day 240 |
|
|
|
| Primary | Number of Participants With Physical Examination Abnormalities Reported as TEAEs | Adverse events observed in participants with clinically significant physical abnormalities were assessed. | As-treated population included participants who received any study drug and summarized according to the treatment they actually received. | Posted | Count of Participants | Participants | From the start of study drug administration upto Day 240 |
|
|
|
| Primary | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed. | As-treated population included participants who received any study drug and summarized according to the treatment they actually received. | Posted | Count of Participants | Participants | From the start of study drug administration upto Day 240 |
|
|
|
| Primary | Number of Participants With TEAEs Related to Injection Site Reactions | Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed. | As-treated population included participants who received any study drug and summarized according to the treatment they actually received. | Posted | Count of Participants | Participants | From the start of study drug administration upto Day 240 |
|
|
|
| Secondary | Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314 | The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314. | Pharmacokinetic (PK) population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | µg*d/mL | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
|
|
|
| Secondary | Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast) | The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314. | The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | μg*d/mL | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
|
|
|
| Secondary | Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314 | The maximum observed serum drug concentration of MEDI9314. | PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. | Posted | Mean | Standard Deviation | µg/mL | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
|
|
|
| Secondary | Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314 | The time to maximum observed serum drug concentration of MEDI9314. | PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. | Posted | Median | Full Range | Day | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
|
|
|
| Secondary | Terminal Phase Elimination Half-life (t1/2) of MEDI9314 | Terminal phase elimination half-life of MEDI9314 | The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Day | Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240 |
|
|
|
| Secondary | Serum Concentrations of MEDI9314 | Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed. | PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The "Number Analyzed" denotes the number of participants evaluated for this outcome measure. | Posted | Mean | Standard Deviation | μg/mL | Baseline (Day 1 [predose]) and Day 240 |
|
|
|
| Secondary | Number of Participants Positive for Anti-Drug Antibodies to MEDI9314 | Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented. | As-treated population included participants who received any study drug and summarized according to the treatment they actually received. | Posted | Count of Participants | Participants | Baseline (Day 1 [predose]) and Day 240 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 8 |
| 12 |
| EG001 | Cohort 1 | Participants received a single SC injection of MEDI9314 45 milligram (mg) on Day 1. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | Cohort 2 | Participants received a single SC injection of MEDI9314 150 mg on Day 1. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | Cohort 3 | Participants received a single SC injection of MEDI9314 300 mg on Day 1. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | Cohort 4 | Participants from Japan received a single SC injection of MEDI9314 300 mg on Day 1 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Cohort 5 | Participants received a single IV infusion of MEDI9314 300 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. All participants in this group did not receive the complete planned dose as per protocol. The error in operating the infusion pump resulted in receiving a dose of 247.5 mg instead of the intended 300 mg dose. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG006 | Cohort 6 | Participants received a single IV infusion of MEDI9314 450 mg using a syringe infusion pump over 60 to 90 minutes on Day 1. | 0 | 6 | 0 | 6 | 5 | 6 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Infusion site bruising | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Infusion site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Skin bacterial infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Myalgia intercostal | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going 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.
| Transaminases increased |
|
| Infusion site erythema |
|
| Infusion site pruritus |
|
| Injection site bruising |
|
| Injection site erythema |
|
| Injection site haemorrhage |
|
| Injection site induration |
|
| Injection site pain |
|
| Injection site pruritus |
|
| Injection site warmth |
|
|
| Day 240 |
|
|
|
| Day 240- ADA positive |
|
|