Single Ascending Dose Study of MEDI1341 in Healthy Volunteers
NCT ID: NCT03272165
Last Updated: 2022-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2017-10-17
2021-03-31
Brief Summary
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Each participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled assessments over a period of 13 weeks.
The main aim of the study is to assess the safety and tolerability of single doses of MEDI1341 in healthy volunteers.
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Detailed Description
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The study will include up to 6 planned cohorts; each cohort will comprise 8 participants. Within each cohort, 6 participants will be randomized to receive MEDI1341 and 2 will be randomized to receive placebo. A Safety Review Committee will review data from each cohort before progression to the next higher dose cohort occurs. On Day 1, each randomized participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. Additional study assessments will occur on Days 2, 4, 8, 15, 22, 29, 43, 57, and 92.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive a single intravenous (IV) infusion of placebo matched to MEDI1341 and will be followed up for 13 weeks.
Placebo
Participants will receive IV infusion of placebo matched to MEDI1341.
Cohort 1: MEDI1341 Dose 1
Participants will receive a single IV infusion of MEDI1341 Dose 1 and will be followed up for 13 weeks.
MEDI1341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Cohort 2: MEDI1341 Dose 2
Participants will receive a single IV infusion of MEDI1341 Dose 2 and will be followed up for 13 weeks.
MEDI1341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Cohort 3: MEDI1341 Dose 3
Participants will receive a single IV infusion of MEDI1341 Dose 3 and will be followed up for 13 weeks.
MEDI1341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Cohort 4: MEDI1341 Dose 4
Participants will receive a single IV infusion of MEDI1341 Dose 4 and will be followed up for 13 weeks.
MEDI1341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Cohort 5: MEDI1341 Dose 5
Participants will receive a single IV infusion of MEDI1341 Dose 5 and will be followed up for 13 weeks.
MEDI1341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Cohort 6: MEDI1341 Dose 6
Participants will receive a single IV infusion of MEDI1341 Dose 6 and will be followed up for 13 weeks.
MEDI1341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Interventions
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MEDI1341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
Placebo
Participants will receive IV infusion of placebo matched to MEDI1341.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m\^2, inclusive
* Participants must have a 12-lead electrocardiogram recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study
* Participants must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening.
Exclusion Criteria
* Considered to be at a high risk of developing a stroke
* Significant medical history of dizziness, blackouts, fainting, or vaso-vagal attacks
* History of any significant ophthalmic disorder, including congenital, genetic or acquired conditions affecting the retina or choroid
* History of severe allergy or history of hypersensitivity to immunizations or immunoglobulins
* History of any significant psychiatric disorder
* History of alcohol abuse
* History of cancer within 5 years of screening
* History of drug abuse
* Any contraindication to Lumbar Puncture
* Any clinically significant abnormality in ECG rhythm, conduction or morphology
* Positive serologic findings at screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies
* Use of prescription or non-prescription drugs
* For female participants, a positive serum or urine pregnancy test result at screening
18 Years
80 Years
ALL
Yes
Sponsors
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Covance
INDUSTRY
MMS Holdings, Inc
UNKNOWN
Catalent
INDUSTRY
Takeda
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jeanelle Kam, MD, CPI
Role: PRINCIPAL_INVESTIGATOR
Covance Dallas CRU, USA
John E Blanchard, MD
Role: PRINCIPAL_INVESTIGATOR
Covance Madison CRU, USA
Locations
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Research Site
Dallas, Texas, United States
Research Site
Madison, Wisconsin, United States
Countries
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Other Identifiers
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D6340C00001
Identifier Type: -
Identifier Source: org_study_id
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