Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

AstraZeneca50 enrolled

Overview

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 comprise 8 participants. 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.

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson's Disease

Interventions

MEDI1341DRUG

Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.

PlaceboDRUG

Participants will receive IV infusion of placebo matched to MEDI1341.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (2)

Research Site

Dallas, Texas, United States

Research Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Time frame: Day 1 through 92 days after a single dose of study drug

Number of Participants With Abnormal Vital Signs, Physical and Neurological Examinations, and Body Weight Measurements Reported as TEAEs

Vital signs assessment included body temperature, respiration rate, pulse rate, and blood pressure. Participants with abnormal vital signs, physical and neurological examinations, and body weight measurements reported as TEAEs are reported.

Time frame: Day 1 through 92 days after a single dose of study drug

Change from Baseline in 12-Lead Electrocardiogram (ECG) Data in Paper and Digital Recordings (PR Interval, QRS Duration, QT Interval, QTcF Interval, and RR Interval)

Changes from baseline in 12-Lead ECG data in paper recordings (PR interval, QRS duration, QT interval, and QTcF interval) and digital recordings (PR interval, QRS duration, QT interval, QTcF interval, and RR interval) are reported.

Time frame: 12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92

Change from Baseline in Heart Rate by 12-Lead ECG in Paper and Digital Recordings

Change from baseline in heart rate by 12-Lead ECG in paper and digital recordings are reported.

Time frame: 12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92

Data from ClinicalTrials.gov

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