Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers

August 4, 2015 updated by: Protalix

A Phase 1, Randomized, Parallel-Design, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers

: This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days. Subjects will remain at the clinical center for 24 hours after the first administration (Day 1) of OPRX-106 including PK sampling and then return to the site daily for additional administrations and study procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male age 18-45
  • Body mass index (BMI) 18-30 kg/m2
  • Male subjects or their partners must use an adequate method of contraception at all times during the study.
  • Negative laboratory tests for HIV, HBcAb and HCV at the screening visit
  • Naïve to any previous recombinant protein therapy
  • Provide written informed consent
  • Have the ability to understand the requirements of the study and to comply with the study protocol and dosing regimen

Exclusion Criteria:

  • Clinical evidence of any active significant disease that could potentially compromise the ability of the Investigator to evaluate or interpret the effects of the study treatment on safety assessment, thus increasing the risk to the subject to unacceptable levels
  • Presence of any acute or chronic diseases
  • History of any allergies or protein-drug hypersensitivity
  • Exposure to long-term steroid treatment within the last 12 months prior to the study
  • Subject had a major operation in last 6 months
  • Subject has received immunosuppressive treatment prior to the study
  • Chronic use of any medication including vitamins
  • Participation in another clinical trial during the previous 3 months (subject report)
  • Reported history of alcohol or drug abuse
  • Subjects with short bowel (more than 1 m removed of small bowel).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 mg
OPRX-106 2 mg oral once daily for 5 days
Drug: OPRX-106
Other Names:
  • TNF receptor-Fc fusion protein (TNFR-Fc)
Experimental: 8 mg
OPRX-106 8 mg oral once daily for 5 days
Drug: OPRX-106
Other Names:
  • TNF receptor-Fc fusion protein (TNFR-Fc)
Experimental: 16 mg
OPRX-106 16 mg oral once daily for 5 days
Drug: OPRX-106
Other Names:
  • TNF receptor-Fc fusion protein (TNFR-Fc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 5 days
Adverse events from subject reporting or other assessments
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve
Time Frame: 24 hours
OPRX-106 concentrations measured at 0, 2, 4, 6, 8,10, 12, 14, 16 and 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protalix

Investigators

  • Study Director: Einat Almon, PdH, Protalix Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PB-106-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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