Safety and Bioavailability of IV and SC LBR-101

Completed · Phase 1 · Has a placebo group

Conditions studied: Bioavailability and Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT01991509

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

36

Starts

2013-10-01

Expected to finish

2015-01-01

Last updated by the study team

2015-03-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• PPD Development — Austin, Texas, United States

Full record on ClinicalTrials.gov

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