Status:
COMPLETED
Single Ascending Dose Study of MEDI1341 in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Covance
MMS Holdings, Inc
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a study of single ascending intravenous doses of MEDI1341 or placebo in up to 48 healthy volunteers, aged 18 to 65 years. The study will include up to 6 planned cohorts; each cohort will compr...
Detailed Description
This is a randomized, double-blind, placebo-controlled study of single ascending intravenous doses of MEDI1341 in male and nonfertile female healthy volunteers, aged 18 to 65 years. The study will in...
Eligibility Criteria
Inclusion
- Participants must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening
- 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
- Nicotine use within 6 months before screening
- 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
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03272165
Start Date
October 17 2017
End Date
March 31 2021
Last Update
June 9 2022
Active Locations (2)
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1
Research Site
Dallas, Texas, United States, 75247
2
Research Site
Madison, Wisconsin, United States, 53704