Status:
COMPLETED
Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase (prGCD)
Lead Sponsor:
Protalix
Conditions:
Gaucher Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD)leading to reduced activity of the lysosomal enzyme glucocerebrosidase ...
Eligibility Criteria
Inclusion
- Healthy male or female between 18 and 45 years of age.
- Female subjects must agree to use a medically acceptable method of contraception at all times during the study and must have a negative serum pregnancy test at baseline and during the study period.
- Females of child-bearing potential must be non-pregnant and not lactating and using adequate birth control such as oral contraceptives.
- Negative laboratory tests for HIV, HBsAg or HCV.
- Naive 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
- Have 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 and thus increase the risk to the subject to unacceptable levels.
- Are pregnant or nursing.
- Presence of any acute or chronic diseases.
- Have a history of any allergies.
- Have been exposed to long-term steroid treatment.
- Had a minor operation in the last 6 months.
- Have ever been exposed to any previous recombinant protein therapy.
- Have received immuno-suppressive treatment.
- Have a positive HIV, HBsAG and HCV laboratory result.
- Use any medication other than vitamins or oral contraceptives (for female).
- Have participated in another clinical trial during the previous 3 months
- Have history of alcohol or drug abuse.
- Are considered by the Investigator to be unsuitable candidate for this study.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00258778
Start Date
November 1 2005
End Date
January 1 2006
Last Update
December 5 2006
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.