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

Regeneron Pharmaceuticals40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

REGN3500DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Site 1

Ghent, Belgium

Outcomes

Primary Outcomes

The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500

Time frame: Up to 293 days after dosing

Secondary Outcomes

Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500

Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing

Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500

Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing

Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500

Time frame: Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing

Data from ClinicalTrials.gov

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