Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
December 5, 2013 updated by: Sanofi
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Investigational Site Number 840001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SAR231893 (REGN668) Drug Product (DP) 1
SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection
|
Pharmaceutical form:solution Route of administration: subcutaneous
|
|
Experimental: SAR231893 (REGN668) Drug Product (DP) 2
SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection
|
Pharmaceutical form:solution Route of administration: subcutaneous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of serum concentrations of SAR231893 (REGN668)
Time Frame: Up to 57 Days
|
Up to 57 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain evaluation at injection site using Visual Analog Scale (VAS)
Time Frame: Up to 8 Days
|
Up to 8 Days
|
|
Erythema at injection site by measuring diameter
Time Frame: Up to 8 Days
|
Up to 8 Days
|
|
Edema at injection site by measuring diameter
Time Frame: Up to 8 Days
|
Up to 8 Days
|
|
Number of participants experiencing adverse events
Time Frame: Up to 57 Days
|
Up to 57 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
February 17, 2012
First Submitted That Met QC Criteria
February 22, 2012
First Posted (Estimate)
February 23, 2012
Study Record Updates
Last Update Posted (Estimate)
December 6, 2013
Last Update Submitted That Met QC Criteria
December 5, 2013
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKM12350
- U1111-1119-3152 (Other Identifier: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.