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

NCT ID: NCT02958436

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-10-03

Brief Summary

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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

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Conditions

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Healthy Volunteers

Keywords

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Safety Tolerability Pharmacokinetics REGN3500

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

Dose regimen 1 of REGN3500 (IV) versus placebo

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 2

Dose regimen 2 of REGN3500 (IV) versus placebo

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 3

Dose regimen 3 of REGN3500 (IV) versus placebo

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 4

Dose regimen 4 of REGN3500 (SC) versus placebo

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Placebo

Intervention Type DRUG

Cohort 5

Dose regimen 5 of REGN3500 (IV) versus placebo

Group Type EXPERIMENTAL

REGN3500

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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REGN3500

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Site 1

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29.

Reference Type DERIVED
PMID: 34523807 (View on PubMed)

Other Identifiers

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2016-002012-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R3500-HV-1551

Identifier Type: -

Identifier Source: org_study_id