Phase 1 Placebo-controlled,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Adults (MEDI8852)
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| ClinicalTrials.gov Identifier: NCT02350751 |
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Recruitment Status :
Completed
First Posted : January 30, 2015
Last Update Posted : July 13, 2015
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Sponsor:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
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Brief Summary:
The purpose of this study is to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Influenza | Drug: MEDI8852 Drug: Placebo | Phase 1 |
This is a phase 1, single-dose, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and pharmacokinetics of MEDI8852 compared to placebo when administered to healthy adult subjects. Approximately 40 subjects will be entered to receive treatment across 4 fixed dose cohorts at 1 site. Investigational product will be delivered intravenously (IV). A total of 4 different dose levels of investigational product will be evaluated across the cohorts. Subjects will be followed for approximately 100 days.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 94 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Double-blind, Single-dose, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults |
| Study Start Date : | January 2015 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: MEDI8852
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) supplied as 50 mg/mL solution for infusion. MEDI8852 is being evaluated for treatment of patients hospitalized with influenza A.
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Drug: MEDI8852 |
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Placebo Comparator: Placebo
Solution containing no active ingredients
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Drug: Placebo |
Primary Outcome Measures :
- Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852 [ Time Frame: 100 days postdose ]Occurrence of adverse events, serious adverse events, adverse events of special interest, and new onset chronic disease.
- Number of Participants with Adverse Events as a Measure of Safety and tolerability of MEDI8852 [ Time Frame: 28 days postdose ]Clinical laboratory assessments (ie, serum chemistry, hematology, and urinalysis)
Secondary Outcome Measures :
- Pharmacokinetics of MEDI8852 in serum: terminal-phase elimination (t½) [ Time Frame: 100 days postdose ]This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
- Pharmacokinetics of MEDI8852 in serum: systemic clearance (CL) [ Time Frame: 100 days postdose ]This variable will be estimated for MEDI8852 in the IV cohorts where the data allows.
- Pharmacokinetics of MEDI8852 in serum: time to maximum serum concentration (Cmax) [ Time Frame: 100 days postdose ]This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
- Pharmacokinetics of MEDI8852 in serum: area under the concentration time curve from 0 to t (AUC 0-t) and from 0 to infinity (AUC 0-inf) [ Time Frame: 100 days postdose ]This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
- Incidence of anti-drug antibody to MEDI8852 in serum [ Time Frame: 100 days postdose ]This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
- Pharmacokinetics of MEDI8852 in serum:volume at steady state (Vss) [ Time Frame: 100 days postdose ]This variable will be estimated for MEDI8852 in the IV cohorts where the data allow.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age 18 through 65 years at the time of screening
- Weight ≥ 45 kg and ≤ 110 kg at screening
- Healthy by medical history, physical examination, and baseline safety laboratory studies.
- Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening
- Electrocardiogram without clinically significant abnormalities at screening
- Able to complete the follow-up period through Day 101 as required by the protocol
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 28 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study
Exclusion Criteria:
- Acute illness, including fever > 99.5°F, on day prior to or day of planned dosing
- Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine. and other nutritional supplements that have not been taken for at least 30 days prior to enrollment, are not exclusionary.
- Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening
- Receipt of immunoglobulin or blood products within 6 months prior to screening
- Receipt of any vaccine within 14 days prior to investigational product dosing or planned receipt of any influenza vaccine within 100 days after investigational product dosing
- Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine above the upper limit of normal or hemoglobin, white blood cell count, or platelet count below the lower limit of normal at screening
- History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years
- Pregnant or nursing mother
- History of alcohol or drug abuse within the past 2 years tha OR positive Class A drug screen for amphetamines, barbiturates, opiates, or cocaine at screening.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350751
Locations
| United States, Kansas | |
| Research Site | |
| Overland Park, Kansas, United States | |
Sponsors and Collaborators
MedImmune LLC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT02350751 |
| Other Study ID Numbers: |
D6000C00001 |
| First Posted: | January 30, 2015 Key Record Dates |
| Last Update Posted: | July 13, 2015 |
| Last Verified: | July 2015 |
Keywords provided by MedImmune LLC:
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Influenza, Flu, Flu A, Influenza A |
Additional relevant MeSH terms:
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Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Diseases MEDI8852 Antiviral Agents Anti-Infective Agents |