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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01537640

Run by

Sanofi

People needed

30

Starts

2012-02-01

Expected to finish

2012-07-01

Last updated by the study team

2013-12-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

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
• 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.

Where it is running

• Investigational Site Number 840001 — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.