Clinical trial NCT01537640: Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
Official title: A Randomized, Double-Blind, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of serum concentrations of SAR231893 (REGN668)
timeFrame: Up to 57 Days
Secondary outcomes:
measure: Pain evaluation at injection site using Visual Analog Scale (VAS)
timeFrame: Up to 8 Days
measure: Erythema at injection site by measuring diameter
timeFrame: Up to 8 Days
measure: Edema at injection site by measuring diameter
timeFrame: Up to 8 Days
measure: Number of participants experiencing adverse events
timeFrame: Up to 57 Days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Investigational Site Number 840001
state: Florida
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.