Safety and Bioavailability of IV and SC LBR-101

Phase 1

Completed

• Conditions: Bioavailability and Pharmacokinetics
• Interventions: Biological: LBR-101 SC; Biological: LBR-101 IV

• Registration Number: NCT01991509
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo SC	LBR-101 SC	Placebo Administered Subcutaneously
LBR-101 Dose 2 SC	LBR-101 SC	LBR-101 Dose 2 Administered Subcutaneously
Placebo IV	LBR-101 IV	Placebo Administered Intravenously
LBR-101 SC Dose 1	LBR-101 SC	LBR-101 Dose 1 Administered Subcutaneously
LBR-101 IV Dose 1	LBR-101 IV	LBR-101 Dose 1 Administered Intravenously
LBR-101 Dose 2 IV	LBR-101 IV	LBR-101 Dose 2 Administered Intravenously

Primary Outcome Measures

Name	Time	Method
Relative bioavailability of IV versus SC Administration of LBR-101	30 Days

Trial Locations

Locations (1)

PPD Development; 🇺🇸 Austin, Texas, United States