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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: REGN1033

• Registration Number: NCT02741739
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

Secondary Objective: Assess safety and tolerability of REGN1033.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-04
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-18
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Key

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Drug	REGN1033	REGN1033 Reference Formulation
Test Drug	REGN1033	REGN1033 Test Formulation

Primary Outcome Measures

Name	Time	Method
Serum REGN1033 concentration-time curve (AUC)	Pre-dose to day 57
Peak REGN1033 concentration (Cmax)	Pre-dose to day 57

Secondary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study	Day 1 to end of study (Day 57)
Presence or absence of anti-drug antibody (ADA)	Day 1 to end of study (Day 57)