Safety and Bioavailability of IV and SC LBR-101

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Bioavailability and Pharmacokinetics

Treatments: Biological: LBR-101 IV; Biological: LBR-101 SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01991509

LBR-101-011

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 6 patient groups, including a placebo group

LBR-101 IV Dose 1

Experimental group

Description:

LBR-101 Dose 1 Administered Intravenously

Treatment:

Biological: LBR-101 IV

LBR-101 SC Dose 1

Experimental group

Description:

LBR-101 Dose 1 Administered Subcutaneously

Treatment:

Biological: LBR-101 SC

Placebo IV

Placebo Comparator group

Description:

Placebo Administered Intravenously

Treatment:

Biological: LBR-101 IV

Placebo SC

Placebo Comparator group

Description:

Placebo Administered Subcutaneously

Treatment:

Biological: LBR-101 SC

LBR-101 Dose 2 IV

Experimental group

Description:

LBR-101 Dose 2 Administered Intravenously

Treatment:

Biological: LBR-101 IV

LBR-101 Dose 2 SC

Experimental group

Description:

LBR-101 Dose 2 Administered Subcutaneously

Treatment:

Biological: LBR-101 SC