NCT02958436

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

October 25, 2016

Last Update Submit

November 6, 2017

Conditions

Healthy Volunteers

Keywords

SafetyTolerabilityPharmacokineticsREGN3500

Outcome Measures

Primary Outcomes (1)

  • The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500

    Up to 293 days after dosing

Secondary Outcomes (3)

  • 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

Study Arms (5)

Cohort 1

EXPERIMENTAL

Dose regimen 1 of REGN3500 (IV) versus placebo

Drug: REGN3500Drug: Placebo

Cohort 2

EXPERIMENTAL

Dose regimen 2 of REGN3500 (IV) versus placebo

Drug: REGN3500Drug: Placebo

Cohort 3

EXPERIMENTAL

Dose regimen 3 of REGN3500 (IV) versus placebo

Drug: REGN3500Drug: Placebo

Cohort 4

EXPERIMENTAL

Dose regimen 4 of REGN3500 (SC) versus placebo

Drug: REGN3500Drug: Placebo

Cohort 5

EXPERIMENTAL

Dose regimen 5 of REGN3500 (IV) versus placebo

Drug: REGN3500Drug: Placebo

Interventions

REGN3500DRUG
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
PlaceboDRUG
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

Ghent, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 34523807DERIVED

MeSH Terms

Interventions

itepekimab

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

November 8, 2016

Study Start

August 1, 2016

Primary Completion

June 18, 2017

Study Completion

October 3, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

BE(1)