Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

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 comprise 8 subjects.

Each subject 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborators: Catalent; Covance; MMS Holdings, Inc

Criteria

Inclusion Criteria:

• Subjects must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening

• Subjects must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m2, inclusive

• Subjects must have a 12-lead ECG recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study

• Subjects 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 subjects, a positive serum or urine pregnancy test result at screening