Lupus Erythematosus, Systemic
Conditions
Keywords
lupus
Brief summary
The study will be a non-randomized, open label, single dose, placebo control, single center, and single arm study in healthy subjects. The study will include one administration of placebo and four single administrations of Oshadi D in two different dose levels, administered in two feeding regimen for the evaluation of the influence of food on Oshadi D absorption.
Interventions
DRUGOshadi D
oral administration
Sponsors
Oshadi Drug Administration
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy Male/female 21 years old and up. * Subject must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements. * Subject must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
Exclusion criteria
* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results. * Subject with positive HIV serology or positive HBsAg at screening. * History or evidence of any active liver disease. * Female subject who are breastfeeding or have a positive pregnancy test at screening or at any time during the study. * Inability to give written informed consent * History of alcohol or drug abuse within 6 months of screening. * Subject who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening. * Mental disorders. * Subject with poor venous access * Significant swallowing disorders * Digestive disorders; * Small bowel surgery; * Mall absorption disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DNase activity level (Kunitz/mL) for 2 dose levels, and different food regimen | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Maximum plasma DNase concentration (ng/mL) in different food regimen and dose levels | 24 hours |
Countries
Israel
Outcome results
None listed