Safety and Bioavailability of IV and SC LBR-101
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/30/2013 |
| Start Date: | October 2013 |
| Contact: | PPD Development |
| Phone: | 512-447-2985 |
A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study Assessing the Safety, Tolerability and Pharmacokinetics of Two Different Doses of LBR-101 Given Intravenously and Subcutaneously
The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101
when administered intravenously or subcutaneously to healthy volunteers.
Inclusion Criteria:
- Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and
able to comply with CRU rules regulations and study schedule
Exclusion Criteria:
- Clinically significant medical or psychiatric condition, Febrile illness within 5
days of dosing, Pregnant or Nursing Females. History of alcoholism, drug addiction or
positive drug/alcohol screen, History of hypersensitivity to injected proteins or
monoclonal antibodies, Unwilling or unable to comply with the protocol specified
lifestyle guidelines, Investigational site staff members, Use of 3 or more
prescription or non-prescription medications daily, Acetaminophen use in doses of
higher than 1 g or more/day, Daily Aspirin use in higher than 325 mg/day, Treatment
with an investigational drug within 30 days of dosing, Use of biologics within 6
months of screening, Any clinically significant abnormality in the 12-Lead ECG,
Positive result for HIV, Hepatitis B, or Hepatitis C, Any clinically significant
abnormalities in Blood Chemistry Hematology or Urinalysis, Positive Pregnancy Test.
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