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

NCT02107833 | Completed Phase 1

• 1 other identifier: PB-106-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

: 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.

Conditions

Human Volunteer

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Adverse events from subject reporting or other assessments

  5 days

Secondary Outcomes (1)

• Area under the curve

  24 hours

Study Arms (3)

2 mg

EXPERIMENTAL

OPRX-106 2 mg oral once daily for 5 days

Drug: OPRX-106

8 mg

EXPERIMENTAL

OPRX-106 8 mg oral once daily for 5 days

Drug: OPRX-106

16 mg

EXPERIMENTAL

OPRX-106 16 mg oral once daily for 5 days

Drug: OPRX-106

Interventions

OPRX-106 DRUG

Also known as: TNF receptor-Fc fusion protein (TNFR-Fc)

16 mg; 2 mg; 8 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Protalix: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Einat Almon, PdH

  Protalix Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

IL (1)