Single Ascending Dose Study of PRX003 in Healthy Subjects

• Sponsor: Prothena Biosciences Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02458677
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 9.1
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: PRX003; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Healthy Subjects
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRX003	Drug: PRX003
Placebo Comparator: Placebo	Other: Placebo

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability as determined by number of subjects with adverse events [Up to 3 months]

2. Determination of pharmacokinetics parameters-(Cmax) [Up to 3 months]

   maximum concentration (Cmax)

3. Determination of pharmacokinetics parameters-(AUClast) [Up to 3 months]

   area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)

4. Determination of pharmacokinetics parameters-(AUCinf) [Up to 3 months]

   area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

5. Determination of pharmacokinetics parameters-elimination rate constant [Up to 3 months]

   elimination rate constant

6. Determination of pharmacokinetics parameters-(t½) [Up to 3 months]

   terminal elimination half life (t½)

7. Determination of pharmacokinetics parameters-(CL) [Up to 3 months]

   clearance (CL)

8. Determination of pharmacokinetics parameters-(Vd) [Up to 3 months]

   apparent volume of distribution (Vd)

Secondary Outcome Measures

1. Immunogenicity as determined by measurement of anti-PRX003 antibodies [Up to 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Worldwide Clinical Trials Early Phase Services	San Antonio	Texas	United States

Sponsors and Collaborators

• Prothena Biosciences Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prothena Biosciences Limited
• ClinicalTrials.gov Identifier: NCT02458677
• Other Study ID Numbers: PRX003-CL001
• First Posted: Jun 1, 2015
• Last Update Posted: Mar 16, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Mar 16, 2016