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Completed

NCT Number: NCT02107833

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.

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Key information

Conditions

Human Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hadassah Medical Organization

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

OPRX-106

Drug

Other names: TNF receptor-Fc fusion protein (TNFR-Fc)

Primary outcomes

  1. Adverse Events

    Time frame: 5 days

    Adverse events from subject reporting or other assessments

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Protalix

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2014
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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