Safety and Bioavailability of IV and SC LBR-101
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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 12, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 4, 2015
March 1, 2015
1.2 years
November 12, 2013
March 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Relative bioavailability of IV versus SC Administration of LBR-101
30 Days
Study Arms (6)
LBR-101 IV Dose 1
EXPERIMENTALLBR-101 Dose 1 Administered Intravenously
LBR-101 SC Dose 1
EXPERIMENTALLBR-101 Dose 1 Administered Subcutaneously
Placebo IV
PLACEBO COMPARATORPlacebo Administered Intravenously
Placebo SC
PLACEBO COMPARATORPlacebo Administered Subcutaneously
LBR-101 Dose 2 IV
EXPERIMENTALLBR-101 Dose 2 Administered Intravenously
LBR-101 Dose 2 SC
EXPERIMENTALLBR-101 Dose 2 Administered Subcutaneously
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PPD Development
Austin, Texas, 78744, United States
Study Officials
- STUDY CHAIR
Marcelo Bigal, MD, PhD
Sponsor Chief Medical Officer
- STUDY DIRECTOR
Rafael Escandon, PhD MPH
Sponsor Clinical VP
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2013
First Posted
November 25, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2014
Study Completion
January 1, 2015
Last Updated
March 4, 2015
Record last verified: 2015-03