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

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958436
• Other study ID #: R3500-HV-1551
• Secondary ID: 2016-002012-41
• Status: Completed
• Phase: Phase 1
• First received: October 25, 2016
• Last updated: November 6, 2017
• Start date: August 2016
• Est. completion date: October 3, 2017

Study information

• Verified date: November 2017
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 3, 2017
• Est. primary completion date: June 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN3500

• Placebo

Locations

Country	Name	City	State
Belgium	Site 1	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500		Up to 293 days after dosing
Secondary	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
Secondary	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
Secondary	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