A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: REGN3500

Study type: Interventional

Funder types: Industry

Identifiers

NCT02958436

2016-002012-41 (EudraCT Number)

R3500-HV-1551

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index</= 33 kg/m2
• In good health based on medical history, physical examination, vital signs, and laboratory testing
• Normal electrocardiogram (ECG) and blood pressure
• Able to comply with clinic visits and study-related procedures
• Able to sign an informed consent

Exclusion criteria

• Significant abnormalities in hematology, clinical chemistry, urinalysis, medical history
• Current smoker or recent history (within 3 months)
• History of tuberculosis, HIV, or hepatic disease
• Known sensitivity to doxycycline or other ingredients of study drug
• History of multiple/severe allergies
• Pregnant or breastfeeding women, or not currently using adequate contraception
• Participation in another investigational drug study within 4 weeks

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Dose regimen 1 of REGN3500 (IV) versus placebo

Treatment:

Drug: REGN3500

Drug: Placebo

Cohort 2

Experimental group

Description:

Dose regimen 2 of REGN3500 (IV) versus placebo

Treatment:

Drug: REGN3500

Drug: Placebo

Cohort 3

Experimental group

Description:

Dose regimen 3 of REGN3500 (IV) versus placebo

Treatment:

Drug: REGN3500

Drug: Placebo

Cohort 4

Experimental group

Description:

Dose regimen 4 of REGN3500 (SC) versus placebo

Treatment:

Drug: REGN3500

Drug: Placebo

Cohort 5

Experimental group

Description:

Dose regimen 5 of REGN3500 (IV) versus placebo

Treatment:

Drug: REGN3500

Drug: Placebo