Single Ascending Dose Study of PRX003 in Healthy Subjects

Prothena

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Other: Placebo; Drug: PRX003

Study type: Interventional

Funder types: Industry

Identifiers

NCT02458677

PRX003-CL001

Details and patient eligibility

About

This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 40 healthy subjects.

Enrollment: 40 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects
• Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 45 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 TB, hepatitis B, hepatitis C or HIV infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

PRX003

Experimental group

Treatment:

Drug: PRX003

Placebo

Placebo Comparator group

Treatment:

Other: Placebo