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

A Randomized, Open-Label, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of REGN1033 Produced From Two Different Cell Lines in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02741739

Enrollment

Registered

2016-04-18

Start date

2016-03-31

Completion date

2016-05-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Drug concentration, REGN1033, blood

Brief summary

Primary Objective: Determine blood concentrations of two formulations of REGN1033. Secondary Objective: Assess safety and tolerability of REGN1033.

Interventions

DRUGREGN1033

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Key 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026