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

NCT ID: NCT02255760

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-04
• Study Completion Date: 2015-04-20

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.

Conditions

MEDI3902 for Prevention of P. Aeruginosa Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MEDI3902 - Dose 1

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

Group Type: EXPERIMENTAL

MEDI3902 - Dose 1

Intervention Type: DRUG

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

MEDI3902 - Dose 2

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

Group Type: EXPERIMENTAL

MEDI3902 - Dose 2

Intervention Type: DRUG

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

MEDI3902 - Dose 3

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

Group Type: EXPERIMENTAL

MEDI3902 - Dose 3

Intervention Type: DRUG

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

MEDI3902 - Dose 4

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

Group Type: EXPERIMENTAL

MEDI3902 - Dose 4

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

MEDI3902 - Dose 1

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

Intervention Type: DRUG

MEDI3902 - Dose 2

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

Intervention Type: DRUG

MEDI3902 - Dose 3

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

Intervention Type: DRUG

MEDI3902 - Dose 4

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

MEDI3902; MEDI3902; MEDI3902; MEDI3902

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hasan S. Jafri, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Martha Hernandez-Illas, MD

Role: PRINCIPAL_INVESTIGATOR

MRA Clinical Research, LLC

Locations

Research Site

South Miami, Florida, United States

Countries

United States

Other Identifiers

D5470C00002

Identifier Type: -

Identifier Source: org_study_id