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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort 4
Dose regimen 4 of REGN3500 (SC) versus placebo
Intervention: Placebo
Cohort 5
Dose regimen 5 of REGN3500 (IV) versus placebo
Intervention: REGN3500
Cohort 5
Dose regimen 5 of REGN3500 (IV) versus placebo
Intervention: Placebo
Cohort 1
Dose regimen 1 of REGN3500 (IV) versus placebo
Intervention: REGN3500
Cohort 1
Dose regimen 1 of REGN3500 (IV) versus placebo
Intervention: Placebo
Cohort 2
Dose regimen 2 of REGN3500 (IV) versus placebo
Intervention: REGN3500
Cohort 2
Dose regimen 2 of REGN3500 (IV) versus placebo
Intervention: Placebo
Cohort 3
Dose regimen 3 of REGN3500 (IV) versus placebo
Intervention: REGN3500
Cohort 3
Dose regimen 3 of REGN3500 (IV) versus placebo
Intervention: Placebo
Cohort 4
Dose regimen 4 of REGN3500 (SC) versus placebo
Intervention: REGN3500
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(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)