Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: MEDI1341

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03272165

D6340C00001

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive a single intravenous (IV) infusion of placebo matched to MEDI1341 and will be followed up for 13 weeks.

Treatment:

Drug: Placebo

Cohort 1: MEDI1341 Dose 1

Experimental group

Description:

Participants will receive a single IV infusion of MEDI1341 Dose 1 and will be followed up for 13 weeks.

Treatment:

Drug: MEDI1341

Cohort 2: MEDI1341 Dose 2

Experimental group

Description:

Participants will receive a single IV infusion of MEDI1341 Dose 2 and will be followed up for 13 weeks.

Treatment:

Drug: MEDI1341

Cohort 3: MEDI1341 Dose 3

Experimental group

Description:

Participants will receive a single IV infusion of MEDI1341 Dose 3 and will be followed up for 13 weeks.

Treatment:

Drug: MEDI1341

Cohort 4: MEDI1341 Dose 4

Experimental group

Description:

Participants will receive a single IV infusion of MEDI1341 Dose 4 and will be followed up for 13 weeks.

Treatment:

Drug: MEDI1341

Cohort 5: MEDI1341 Dose 5

Experimental group

Description:

Participants will receive a single IV infusion of MEDI1341 Dose 5 and will be followed up for 13 weeks.

Treatment:

Drug: MEDI1341

Cohort 6: MEDI1341 Dose 6

Experimental group

Description:

Participants will receive a single IV infusion of MEDI1341 Dose 6 and will be followed up for 13 weeks.

Treatment:

Drug: MEDI1341