Clinical trial NCT02255760: Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of MEDI3902 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: MEDI3902 for Prevention of P. Aeruginosa Pneumonia
Keywords: MEDI3902
Safety,
Pharmacokinetics,
Healthy Volunteers
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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:

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

13. History of alcohol or drug abuse within the past 2 years.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 29
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)
timeFrame: Day 1 to Day 61
measure: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 29
measure: Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 7
Secondary outcomes:
measure: Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
timeFrame: 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
measure: Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose
timeFrame: 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
measure: Terminal Phase Elimination Half-life (t1/2)
timeFrame: 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
measure: Volume of Distribution at Steady State (Vss)
timeFrame: 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
measure: MEDI3902 Serum Clearance (CL) of MEDI3902
timeFrame: 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
measure: Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902
timeFrame: Days 1 (pre-dose), 15, 29, and 61
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: MedImmune LLC
name: Hasan S. Jafri, M.D.
role: STUDY_DIRECTOR
affiliation: MRA Clinical Research, LLC
name: Martha Hernandez-Illas, MD
role: PRINCIPAL_INVESTIGATOR
References: