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This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age.
This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age. Approximately 40 subjects will be enrolled across 4 fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 60 day safety follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI3902 - Dose 1 | Experimental | Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
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| MEDI3902 - Dose 2 | Experimental | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
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| MEDI3902 - Dose 3 | Experimental | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
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| MEDI3902 - Dose 4 | Experimental | Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| Placebo | Placebo Comparator | Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI3902 - Dose 1 | Drug | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is 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. | Day 1 to Day 29 |
| Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs) | An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event 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 that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease. | Day 1 to Day 61 |
| Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis. | Day 1 to Day 29 |
| Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) | Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. |
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Inclusion Criteria:
Exclusion Criteria:
13. History of alcohol or drug abuse within the past 2 years.
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| Name | Affiliation | Role |
|---|---|---|
| Hasan S. Jafri, M.D. | MedImmune LLC | Study Director |
| Martha Hernandez-Illas, MD | MRA Clinical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | South Miami | Florida | 33143 | United States |
A total of 131 participants were screened, of which 75 did not meet eligibility criteria and were considered as screen failures; and the remaining 56 participants were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single dose of placebo by intravenous (IV) infusion up to a maximum of 12 hours. |
| FG001 | MEDI3902 - Dose 1 | Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| MEDI3902 - Dose 2 | Drug | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
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| MEDI3902 - Dose 3 | Drug | Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
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| MEDI3902 - Dose 4 | Drug | Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| Placebo | Other | Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours. |
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| Day 1 to Day 7 |
| Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
| Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose | The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
| Terminal Phase Elimination Half-life (t1/2) | The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
| Volume of Distribution at Steady State (Vss) | Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
| MEDI3902 Serum Clearance (CL) of MEDI3902 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
| Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902 | Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented. | Days 1 (pre-dose), 15, 29, and 61 |
| FG002 | MEDI3902 - Dose 2 | Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
| FG003 | MEDI3902 - Dose 3 | Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
| FG004 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
| COMPLETED |
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| NOT COMPLETED |
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Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single dose of placebo by IV infusion up to a maximum of 12 hours. |
| BG001 | MEDI3902 - Dose 1 | Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. |
| BG002 | MEDI3902 - Dose 2 | Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
| BG003 | MEDI3902 - Dose 3 | Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
| BG004 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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) | An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is 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. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Count of Participants | Participants | Day 1 to Day 29 |
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| Primary | Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs) | An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event 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 that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Count of Participants | Participants | Day 1 to Day 61 |
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| Primary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Count of Participants | Participants | Day 1 to Day 29 |
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| Primary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Count of Participants | Participants | Day 1 to Day 7 |
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| Secondary | Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) | Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | micrograms*day/milliliters | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
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| Secondary | Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose | The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | micrograms/milliliter | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
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| Secondary | Terminal Phase Elimination Half-life (t1/2) | The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | Days | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
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| Secondary | Volume of Distribution at Steady State (Vss) | Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | milliliters | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
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| Secondary | MEDI3902 Serum Clearance (CL) of MEDI3902 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | milliliters/day | Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose |
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| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902 | Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented. | Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received. | Posted | Count of Participants | Participants | Days 1 (pre-dose), 15, 29, and 61 |
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Adverse events were collected from the time of signature of informed consent through Day 61 of the study.
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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 dose of placebo by IV infusion up to a maximum of 12 hours. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG001 | MEDI3902 - Dose 1 | Participants received a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | MEDI3902 - Dose 2 | Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. | 0 | 15 | 0 | 15 | 6 | 15 |
| EG003 | MEDI3902 - Dose 3 | Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. | 0 | 15 | 0 | 15 | 8 | 15 |
| EG004 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. | 0 | 9 | 0 | 9 | 6 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Chalazion | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Periorbital contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hasan S. Jafri, MD, Senior Director, Clinical Development | MedImmune LLC | 301-398-0000 | jafrih@medimmune.com |
| ID | Term |
|---|---|
| C000622725 | gremubamab |
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| Male |
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| OG002 | MEDI3902 - Dose 2 | Participants received a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. |
| OG003 | MEDI3902 - Dose 3 | Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. |
| OG004 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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Participants received a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
| OG004 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| OG004 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| OG003 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| MEDI3902 - Dose 4 |
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| OG003 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| MEDI3902 - Dose 4 |
Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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| OG004 | MEDI3902 - Dose 4 | Participants received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. |
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