NCT01537653

Brief Summary

Primary Objective: Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects Secondary Objectives: Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects

  • The pharmacokinetics of SAR231893 (REGN668)
  • The immunogenicity of SAR231893 (REGN668)
  • Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2012

Typical duration for phase_1 healthy

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

First Submitted

Initial submission to the registry

February 17, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 6, 2013

Status Verified

November 1, 2012

Enrollment Period

7 months

First QC Date

February 17, 2012

Last Update Submit

December 5, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)

    Up to 57 days

Secondary Outcomes (2)

  • Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time

    Up to 57 days

  • Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time

    Up to 57 days

Study Arms (5)

SAR231893 (REGN668), Dose Level 4

EXPERIMENTAL

Dose Level 4

Drug: SAR231893 (REGN668)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

SAR231893 (REGN668), Dose Level 1

EXPERIMENTAL

Dose Level 1

Drug: SAR231893 (REGN668)

SAR231893 (REGN668), Dose Level 2

EXPERIMENTAL

Dose Level 2

Drug: SAR231893 (REGN668)

SAR231893 (REGN668), Dose Level 3

EXPERIMENTAL

Dose Level 3

Drug: SAR231893 (REGN668)

Interventions

SAR231893 (REGN668)DRUG

Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection

SAR231893 (REGN668), Dose Level 1SAR231893 (REGN668), Dose Level 2SAR231893 (REGN668), Dose Level 3SAR231893 (REGN668), Dose Level 4
placeboDRUG

Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese adult male subjects, between 20 and 45 years of age, inclusive.
  • Body weight between 50.0 and 95.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m2, inclusive.
  • Certified as healthy by a comprehensive clinical assessment.
  • Having given written informed consent prior to undertaking any study-related procedure.

You may not qualify if:

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
  • Any subject who cannot prohibit intensive physical activity throughout the study duration.
  • Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies.
  • Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • Serum alcohol level over the upper limit of normal range (ULN).
  • Previous exposure to any therapeutic or investigational biological agent.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 392001

Toshima-Ku, 171-0014, Japan

Location

Related Publications (1)

  • Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.

    PMID: 32348036DERIVED

MeSH Terms

Interventions

dupilumab

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 23, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 6, 2013

Record last verified: 2012-11

Locations

JP(1)