Single Ascending Dose Study of PRX002 in Healthy Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.

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

Details

• Lead Sponsor: Prothena Biosciences Limited
• Collaborator: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Healthy subjects

• Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 46 kg

• Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception

• Male subjects and their partners of childbearing potential must use contraception

Exclusion Criteria:

• Positive test for drug of abuse

• Past or current history of alcohol abuse

• Positive for hepatitis B, hepatitis C or HIV infection