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CompletedNCT02255760Updated Aug 13, 2018Results posted

Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults

A Phase 1 interventional study of MEDI3902 - Dose 1 and MEDI3902 - Dose 2 in MEDI3902 for Prevention of P. Aeruginosa Pneumonia, sponsored by MedImmune LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-13.

Sponsored by MedImmune LLC · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • MEDI3902 for Prevention of P. Aeruginosa Pneumonia

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Keywords

  • MEDI3902
  • Safety,
  • Pharmacokinetics,
  • Healthy Volunteers
03

In context

Pneumonia

2,045 studies on the registry are indexed under Pneumonia; 284 are open to participants now.

This study's enrollment of 56 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 18 through 60 years at the time of screening
  2. Written informed consent
  3. Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (\<=) 110 kg at screening
  4. Healthy by medical history, physical examination, and baseline safety laboratory studies
  5. Systolic blood pressure (BP) less than (\<) 140 millimeter of mercury (mmHg) and diastolic BP \< 90 mmHg at screening
  6. Electrocardiogram (ECG) without clinically significant abnormalities at screening
  7. Able to complete the follow-up period through Day 61 as required by the protocol.
  8. Females of childbearing potential who are sexually active with a nonsterilized male partner must have used a highly effective method of contraception for at least 28 days prior to dosing with investigational product and must agree to continue using such precautions through Day 61 of the study.

Exclusion criteria

Exclusion Criteria:

  1. Acute (time-limited) illness, including fever 99.5 degree Fahrenheit (0\^F), on day prior to or day of planned dosing
  2. Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine, or combination over-the-counter (OTC) product that contains acetaminophen with an antihistamine, or OTC non-steroidal anti inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, ie, have been taken for at least 30 days prior to enrolment, are not exclusionary
  3. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
  4. Receipt of immunoglobulin or blood products within 6 months prior to screening
  5. Receipt of any investigational product in the preceding 90 days or expected receipt of investigational product during the period of study follow-up, or concurrent participation in another interventional study Receipt of any vaccine within 7 days prior to investigational product dosing or planned receipt within 61 days after investigational product dosing except for influenza vaccine administered at least 28 days after dosing
  6. Previous receipt of a mAb
  7. Immunodeficiency due to illness, including human immunodeficiency virus (HIV) infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. HIV testing must be negative at screening
  8. History of allergic disease or reactions likely to be exacerbated by any component of the investigational product
  9. Either history of active infection with hepatitis B or C
  10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above the upper limit of normal (ULN) or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening and in the predose blood sample
  11. Pregnant or nursing mother
  1. History of alcohol or drug abuse within the past 2 years.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    MEDI3902 - Dose 1

    Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.

    Drug: MEDI3902 - Dose 1

  • Experimental
    MEDI3902 - Dose 2

    Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.

    Drug: MEDI3902 - Dose 2

  • Experimental
    MEDI3902 - Dose 3

    Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.

    Drug: MEDI3902 - Dose 3

  • Experimental
    MEDI3902 - Dose 4

    Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.

    Drug: MEDI3902 - Dose 4

  • Placebo comparator
    Placebo

    Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.

    Other: Placebo

Interventions

  • DrugMEDI3902 - Dose 1

    Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.

    Also known as: MEDI3902

  • DrugMEDI3902 - Dose 2

    Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.

    Also known as: MEDI3902

  • DrugMEDI3902 - Dose 3

    Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.

    Also known as: MEDI3902

  • DrugMEDI3902 - Dose 4

    Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.

    Also known as: MEDI3902

  • OtherPlacebo

    Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 to Day 29

  2. 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.

    Time frame: Day 1 to Day 61

  3. 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.

    Time frame: Day 1 to Day 29

  4. 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.

    Time frame: Day 1 to Day 7

Secondary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: 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

  3. 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.

    Time frame: 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

  4. 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.

    Time frame: 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

  5. 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.

    Time frame: 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

  6. 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.

    Time frame: Days 1 (pre-dose), 15, 29, and 61

07

Results

Posted Aug 13, 2018

Participant flow

Participant flow — Overall Study
MilestonePlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Started14315159
Completed14215159
Not completed01000
Withdrew: Lost to follow-up01000

Outcome measures

PrimaryNumber 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.

Time frame:
Day 1 to Day 29
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsPlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)42686
PrimaryNumber 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.

Time frame:
Day 1 to Day 61
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)
ParticipantsPlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
TESAEs00000
TEAESIs00465
PrimaryNumber 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.

Time frame:
Day 1 to Day 29
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
ParticipantsPlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)00000
PrimaryNumber 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.

Time frame:
Day 1 to Day 7
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
ParticipantsPlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)00000
SecondaryArea 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.

Time frame:
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
Reported as:
Mean · micrograms*day/milliliters
Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
micrograms*day/millilitersMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])694 ± 1332149 ± 6254246 ± 11176540 ± 1817
SecondaryMaximum 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.

Time frame:
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
Reported as:
Mean · micrograms/milliliter
Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose
micrograms/milliliterMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose100 ± 6207 ± 36468 ± 134838 ± 181
SecondaryTerminal 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.

Time frame:
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
Reported as:
Mean · Days
Terminal Phase Elimination Half-life (t1/2)
DaysMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Terminal Phase Elimination Half-life (t1/2)7.2 ± 0.99.0 ± 2.19.4 ± 1.68.4 ± 0.8
SecondaryVolume 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.

Time frame:
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
Reported as:
Mean · milliliters
Volume of Distribution at Steady State (Vss)
millilitersMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Volume of Distribution at Steady State (Vss)3412 ± 1074022 ± 5774326 ± 12464909 ± 1022
SecondaryMEDI3902 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.

Time frame:
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
Reported as:
Mean · milliliters/day
MEDI3902 Serum Clearance (CL) of MEDI3902
milliliters/dayMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
MEDI3902 Serum Clearance (CL) of MEDI3902371 ± 79371 ± 101373 ± 83489 ± 128
SecondaryNumber 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.

Time frame:
Days 1 (pre-dose), 15, 29, and 61
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
ParticipantsPlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Pre-dose (Baseline)01010
Day 1500000
Day 2900000
Day 6110001

Adverse events

Collected over Adverse events were collected from the time of signature of informed consent through Day 61 of the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/14 (0%)0/14 (0%)4/14 (28.6%)
MEDI3902 - Dose 10/3 (0%)0/3 (0%)2/3 (66.7%)
MEDI3902 - Dose 20/15 (0%)0/15 (0%)6/15 (40%)
MEDI3902 - Dose 30/15 (0%)0/15 (0%)8/15 (53.3%)
MEDI3902 - Dose 40/9 (0%)0/9 (0%)6/9 (66.7%)
Most frequent other events
Showing 10 of 21
Most frequent other events
EventPlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4
Infusion related reactionInjury, poisoning and procedural complications0/140/34/156/155/9
HeadacheNervous system disorders2/141/32/151/152/9
RhinitisInfections and infestations0/141/30/150/150/9
DyspepsiaGastrointestinal disorders0/140/30/150/152/9
PruritusSkin and subcutaneous tissue disorders1/140/30/150/152/9
DiarrhoeaGastrointestinal disorders1/140/30/150/151/9
Upper respiratory tract infectionInfections and infestations0/140/30/150/151/9
Dermatitis bullousSkin and subcutaneous tissue disorders0/140/30/150/151/9
RashSkin and subcutaneous tissue disorders0/140/30/150/151/9
Periorbital contusionInjury, poisoning and procedural complications1/140/30/150/150/9

Baseline characteristics

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.

Age, Continuous
Age, Continuous(Years)PlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4Total
Mean41.2 ± 10.934.0 ± 9.540.9 ± 11.840.3 ± 12.439.8 ± 13.140.3 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboMEDI3902 - Dose 1MEDI3902 - Dose 2MEDI3902 - Dose 3MEDI3902 - Dose 4Total
Female9399636
Male5066320
08

Study locations

1 site
  • Research Site
    South Miami, Florida 33143, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02255760
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
Oct 3, 2014
Start date
Sep 4, 2014
Primary completion
Apr 20, 2015
Completion
Apr 20, 2015
Results posted
Aug 13, 2018
Last update
Aug 13, 2018

Study contacts

Hasan S. Jafri, M.D.
study director · MedImmune LLC
Martha Hernandez-Illas, MD
principal investigator · MRA Clinical Research, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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