NCT02828397

Brief Summary

Primary Objective: Determine blood concentrations of two formulations of REGN2222 Secondary Objective: Assess safety and tolerability of REGN2222

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 4, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

July 7, 2016

Last Update Submit

November 3, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • 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)

Study Arms (2)

Reference Drug

EXPERIMENTAL

REGN2222 Reference Formulation

Drug: REGN2222

Test Drug

EXPERIMENTAL

REGN2222 Test Formulation

Drug: REGN2222

Interventions

REGN2222DRUG
Reference DrugTest Drug

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Daytona Beach, Florida, United States

Location

Unknown Facility

Evansville, Indiana, United States

Location

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 11, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 4, 2016

Record last verified: 2016-11

Locations

US(2)