Study of the Blood Concentrations of Two Formulations of REGN1033 in Healthy Subjects

NCT ID: NCT02741739

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-05-31

Brief Summary

Primary Objective: Determine blood concentrations of two formulations of REGN1033.

Secondary Objective: Assess safety and tolerability of REGN1033.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Reference Drug

REGN1033 Reference Formulation

Group Type: EXPERIMENTAL

REGN1033

Intervention Type: DRUG

Test Drug

REGN1033 Test Formulation

Group Type: EXPERIMENTAL

REGN1033

Intervention Type: DRUG

Interventions

REGN1033

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy males and females (not of childbearing potential) between the ages of 18 and 65 years

2. Body weight between 50.0 kg and 95.0 kg

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

4. Provide signed informed consent

Exclusion Criteria

1. Donation or loss of approximately 400 mL or more of blood within 8 weeks prior to dosing, or plasma up to 14 days prior to dosing

2. Hemoglobin not within normal limits

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

4. Low or elevated blood pressure and/or heart rate after 3 minutes resting in the seated position:

5. Recent use (within 3 months prior to screening) of androgenic steroids

6. 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

7. Previous exposure to any biological therapeutic agent, except vaccines

8. Known sensitivity to tamoxifen, doxycycline, or similar compounds (ie, tetracyclines)

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

San Antonio, Texas, United States

Countries

United States

Other Identifiers

R1033-HV-1503

Identifier Type: -

Identifier Source: org_study_id