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Trial record 2 of 2 for:    OPRX-106

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

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ClinicalTrials.gov Identifier: NCT02107833
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Protalix

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.

Condition or disease Intervention/treatment Phase
Human Volunteer Drug: OPRX-106 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: 2 mg
OPRX-106 2 mg oral once daily for 5 days
Drug: OPRX-106
Other Name: TNF receptor-Fc fusion protein (TNFR-Fc)

Experimental: 8 mg
OPRX-106 8 mg oral once daily for 5 days
Drug: OPRX-106
Other Name: TNF receptor-Fc fusion protein (TNFR-Fc)

Experimental: 16 mg
OPRX-106 16 mg oral once daily for 5 days
Drug: OPRX-106
Other Name: TNF receptor-Fc fusion protein (TNFR-Fc)




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 5 days ]
    Adverse events from subject reporting or other assessments


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107833


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Protalix
Investigators
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Study Director: Einat Almon, PdH Protalix Ltd.

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Responsible Party: Protalix
ClinicalTrials.gov Identifier: NCT02107833     History of Changes
Other Study ID Numbers: PB-106-001
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors