Human Volunteer
Conditions
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.
Interventions
DRUGOPRX-106
Sponsors
Protalix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 5 days | Adverse events from subject reporting or other assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve | 24 hours | OPRX-106 concentrations measured at 0, 2, 4, 6, 8,10, 12, 14, 16 and 24 hours |
Countries
Israel
Outcome results
None listed