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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02958436

Enrollment

Registered

2016-11-08

Start date

2016-08-31

Completion date

2017-10-03

Last updated

2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Safety, Tolerability, Pharmacokinetics, REGN3500

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

Interventions

DRUGREGN3500

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026