Study of the Blood Concentrations of Two Formulations of... | NCT02828397

Studies
Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects

NCT02828397

Sponsor

Regeneron Pharmaceuticals

Status

Completed

Last Update Posted

Nov 4, 2016Estimated

Enrollment

28Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

REGN2222

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

Nov 2016

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

Apr 2016

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Jul 7, 2016

First Submission Date that Met QC Criteria

Jul 7, 2016

First Posted Date

Jul 11, 2016Estimated

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

Nov 3, 2016

Last Update Posted Date

Nov 4, 2016Estimated

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

Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reference Drug	Experimental	REGN2222 Reference Formulation	Drug: REGN2222
Test Drug	Experimental	REGN2222 Test Formulation	Drug: REGN2222

Interventions

Name	Type	Description	Arm Group Labels	Other Names
REGN2222	Drug		Reference Drug Test Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum REGN2222 concentration-time curve (AUC)		Day 1 to Day 148 (end of study)
Peak REGN2222 concentration (Cmax)		Day 1 to Day 148 (end of study)

Secondary Outcomes

Measure	Description	Time Frame
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study		Day 1 to Day 148 (end of study)
Presence or absence of anti-drug antibody (ADA)		Day 1 to Day 148 (end of study)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Healthy man or woman aged 18 to 60 years
Body weight between 50.0 kg and 95.0 kg, inclusive
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent

Key Exclusion Criteria:

Hemoglobin not within normal limits
Positive drug and alcohol screen test results at screening visits 1 and 2
Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
Pregnant or breastfeeding women, and women of childbearing potential
Sexually active men who are unwilling to practice adequate contraception during the study

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
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Daytona Beach	Florida		United States