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CompletedNCT02107833Updated Aug 5, 2015

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

A Phase 1 interventional study of OPRX-106 in Human Volunteer, sponsored by Protalix. Completed at 1 site in Israel. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-05.

Sponsored by Protalix · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

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.

02

Conditions studied

  • Human Volunteer
03

In context

Lead sponsor

Protalix is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    2 mg

    OPRX-106 2 mg oral once daily for 5 days

    Drug: OPRX-106

  • Experimental
    8 mg

    OPRX-106 8 mg oral once daily for 5 days

    Drug: OPRX-106

  • Experimental
    16 mg

    OPRX-106 16 mg oral once daily for 5 days

    Drug: OPRX-106

Interventions

  • DrugOPRX-106

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

06

What researchers measure

Primary outcomes

  1. Adverse Events

    Adverse events from subject reporting or other assessments

    Time frame: 5 days

Secondary outcomes

  1. Area under the curve

    OPRX-106 concentrations measured at 0, 2, 4, 6, 8,10, 12, 14, 16 and 24 hours

    Time frame: 24 hours

07

Study locations

1 site
  • Hadassah Medical Organization
    Jerusalem, Israel
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2014
First posted
Apr 8, 2014
Start
Jul 2014
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
Aug 5, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02107833
Lead sponsor
Protalix
Responsible party
Sponsor
First posted
Apr 8, 2014
Start date
Jul 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Aug 5, 2015

Study contacts

Einat Almon, PdH
study director · Protalix Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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