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

Human Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107833
• Other study ID #: PB-106-001
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2014
• Last updated: August 4, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Protalix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Human Volunteer

Intervention

Drug:
• OPRX-106

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Protalix

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Adverse events from subject reporting or other assessments	5 days	Yes
Secondary	Area under the curve	OPRX-106 concentrations measured at 0, 2, 4, 6, 8,10, 12, 14, 16 and 24 hours	24 hours	No