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Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects

NCT ID: NCT01537640

Last Updated: 2013-12-06

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-07-31

Brief Summary

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Primary Objective:

To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose

Secondary Objective:

To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose

Detailed Description

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The duration of the study for each subject is 8-11 weeks broken down as follows:

* Screening: 2 to 21 days,
* Treatment: 1 day (2 overnight stays at the study site),
* Follow-up: up to 2 months after dosing.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAR231893 (REGN668) Drug Product (DP) 1

SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection

Group Type EXPERIMENTAL

SAR231893 (REGN668) DP1

Intervention Type BIOLOGICAL

Pharmaceutical form:solution Route of administration: subcutaneous

SAR231893 (REGN668) Drug Product (DP) 2

SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection

Group Type EXPERIMENTAL

SAR231893 (REGN668) DP2

Intervention Type BIOLOGICAL

Pharmaceutical form:solution Route of administration: subcutaneous

Interventions

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SAR231893 (REGN668) DP1

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type BIOLOGICAL

SAR231893 (REGN668) DP2

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects between 18 and 45 years of age

Exclusion Criteria

* Presence or history of drug hypersensitivity or allergic disease
* History or presence of dermatological disorders
* Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections
* Prior opportunistic infections within 6 months before inclusion
* History or presence of listeriosis or tuberculosis
* Any vaccination within 3 months (1 month for influenza vaccine) before inclusion
* Any biologics given within 4 months before inclusion
* Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening

The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 840001

Daytona Beach, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32348036 (View on PubMed)

Other Identifiers

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U1111-1119-3152

Identifier Type: OTHER

Identifier Source: secondary_id

PKM12350

Identifier Type: -

Identifier Source: org_study_id