Overview

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