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

NCT02107833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-08-05

No results posted yet for this study

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

Interventions

DRUG

OPRX-106

Sponsors & Collaborators

  • Protalix

    lead INDUSTRY

Principal Investigators

  • Einat Almon, PdH · Protalix Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02107833 on ClinicalTrials.gov