Safety and Bioavailability of IV and SC LBR-101 | NCT01991509

Studies
Safety and Bioavailability of IV and SC LBR-101

NCT01991509

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Completed

Last Update Posted

Mar 4, 2015Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Bioavailability and Pharmacokinetics

Interventions

LBR-101 IV
LBR-101 SC

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Jan 2015Actual

First Submitted Date

Nov 12, 2013

First Submission Date that Met QC Criteria

Nov 18, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2015

Last Update Posted Date

Mar 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LBR-101 IV Dose 1	Experimental	LBR-101 Dose 1 Administered Intravenously	Biological: LBR-101 IV
LBR-101 SC Dose 1	Experimental	LBR-101 Dose 1 Administered Subcutaneously	Biological: LBR-101 SC
Placebo IV	Placebo Comparator	Placebo Administered Intravenously	Biological: LBR-101 IV
Placebo SC	Placebo Comparator	Placebo Administered Subcutaneously	Biological: LBR-101 SC
LBR-101 Dose 2 IV	Experimental	LBR-101 Dose 2 Administered Intravenously	Biological: LBR-101 IV
LBR-101 Dose 2 SC	Experimental	LBR-101 Dose 2 Administered Subcutaneously

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LBR-101 IV	Biological	LBR-101 Administered Intravenously	LBR-101 Dose 2 IV LBR-101 IV Dose 1 Placebo IV

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcelo Bigal, MD, PhD	Sponsor Chief Medical Officer	Study Chair
Rafael Escandon, PhD MPH	Sponsor Clinical VP	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PPD Development		Austin	Texas	78744	United States