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

Study Overview
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Brief Summary
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: 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.

Official Title
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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

Conditions
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Human Volunteer

Intervention / Treatment
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* Drug: OPRX-106


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 mg<br>OPRX-106 2 mg oral once daily for 5 days | Drug: OPRX-106<br> <br> * Other names: TNF receptor-Fc fusion protein (TNFR-Fc);|
| Experimental: 8 mg<br>OPRX-106 8 mg oral once daily for 5 days | Drug: OPRX-106<br> <br> * Other names: TNF receptor-Fc fusion protein (TNFR-Fc);|
| Experimental: 16 mg<br>OPRX-106 16 mg oral once daily for 5 days | Drug: OPRX-106<br> <br> * Other names: TNF receptor-Fc fusion protein (TNFR-Fc);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events from subject reporting or other assessments | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve | OPRX-106 concentrations measured at 0, 2, 4, 6, 8,10, 12, 14, 16 and 24 hours | 24 hours |