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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Intramuscular (IM) Injection of REGN2222 Produced by 2 Different Cell Lines in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828397
• Other study ID #: R2222-HV-1520
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2016
• Last updated: November 3, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Key Inclusion Criteria:

1. Healthy man or woman aged 18 to 60 years

2. Body weight between 50.0 kg and 95.0 kg, inclusive

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Key Exclusion Criteria:

1. Hemoglobin not within normal limits

2. Positive drug and alcohol screen test results at screening visits 1 and 2

3. 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

4. Pregnant or breastfeeding women, and women of childbearing potential

5. Sexually active men who are unwilling to practice adequate contraception during the study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN2222

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum REGN2222 concentration-time curve (AUC)		Day 1 to Day 148 (end of study)	No
Primary	Peak REGN2222 concentration (Cmax)		Day 1 to Day 148 (end of study)	No
Secondary	Treatment-emergent adverse events (TEAEs) from baseline to the end of the study		Day 1 to Day 148 (end of study)	Yes
Secondary	Presence or absence of anti-drug antibody (ADA)		Day 1 to Day 148 (end of study)	Yes