Safety and Bioavailability of IV and SC LBR-101

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bioavailability and Pharmacokinetics

Intervention / Treatment
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* Biological: LBR-101 IV
* Biological: LBR-101 SC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBR-101 IV Dose 1<br>LBR-101 Dose 1 Administered Intravenously | Biological: LBR-101 IV<br>* LBR-101 Administered Intravenously<br>|
| Experimental: LBR-101 SC Dose 1<br>LBR-101 Dose 1 Administered Subcutaneously | Biological: LBR-101 SC<br>* LBR-101 Administered Subcutaneously<br>|
| Placebo Comparator: Placebo IV<br>Placebo Administered Intravenously | Biological: LBR-101 IV<br>* LBR-101 Administered Intravenously<br>|
| Placebo Comparator: Placebo SC<br>Placebo Administered Subcutaneously | Biological: LBR-101 SC<br>* LBR-101 Administered Subcutaneously<br>|
| Experimental: LBR-101 Dose 2 IV<br>LBR-101 Dose 2 Administered Intravenously | Biological: LBR-101 IV<br>* LBR-101 Administered Intravenously<br>|
| Experimental: LBR-101 Dose 2 SC<br>LBR-101 Dose 2 Administered Subcutaneously | Biological: LBR-101 SC<br>* LBR-101 Administered Subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability of IV versus SC Administration of LBR-101 |  | 30 Days |