Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
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
2 other identifiers
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Feb 2012
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
February 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 6, 2013
July 1, 2012
5 months
February 17, 2012
December 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of serum concentrations of SAR231893 (REGN668)
Up to 57 Days
Secondary Outcomes (4)
Pain evaluation at injection site using Visual Analog Scale (VAS)
Up to 8 Days
Erythema at injection site by measuring diameter
Up to 8 Days
Edema at injection site by measuring diameter
Up to 8 Days
Number of participants experiencing adverse events
Up to 57 Days
Study Arms (2)
SAR231893 (REGN668) Drug Product (DP) 1
EXPERIMENTALSAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection
SAR231893 (REGN668) Drug Product (DP) 2
EXPERIMENTALSAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection
Interventions
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:solution Route of administration: subcutaneous
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects between 18 and 45 years of age
You may not qualify if:
- 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
- History or presence of listeriosis or tuberculosis
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Regeneron Pharmaceuticalscollaborator
Study Sites (1)
Investigational Site Number 840001
Daytona Beach, Florida, 32117, United States
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
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
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
February 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
December 6, 2013
Record last verified: 2012-07