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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: REGN3500; Drug: Placebo

• Registration Number: NCT02958436
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Primary Completion: 2017-06-18
• Study Completion: 2017-10-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 5	Placebo	Dose regimen 5 of REGN3500 (IV) versus placebo
Cohort 1	Placebo	Dose regimen 1 of REGN3500 (IV) versus placebo
Cohort 2	Placebo	Dose regimen 2 of REGN3500 (IV) versus placebo
Cohort 1	REGN3500	Dose regimen 1 of REGN3500 (IV) versus placebo
Cohort 2	REGN3500	Dose regimen 2 of REGN3500 (IV) versus placebo
Cohort 4	REGN3500	Dose regimen 4 of REGN3500 (SC) versus placebo
Cohort 4	Placebo	Dose regimen 4 of REGN3500 (SC) versus placebo
Cohort 3	Placebo	Dose regimen 3 of REGN3500 (IV) versus placebo
Cohort 5	REGN3500	Dose regimen 5 of REGN3500 (IV) versus placebo
Cohort 3	REGN3500	Dose regimen 3 of REGN3500 (IV) versus placebo

Primary Outcome Measures

Name	Time	Method
The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500	Up to 293 days after dosing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Site 1; 🇧🇪 Ghent, Belgium