Single Ascending Dose Study of PRX002 in Healthy Subjects

Prothena

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: PRX002; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02095171

PRX002-CL001

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

PRX002

Experimental group

Treatment:

Drug: PRX002

Placebo

Placebo Comparator group

Treatment:

Other: Placebo