- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537640
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
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
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Investigational Site Number 840001
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
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