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Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers

2014-08-27 04:00:29 | BioPortfolio

Summary

This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

REGN668: Injection Rate 1, REGN668: Injection Rate 2

Location

San Antonio
Texas
United States
78209

Status

Completed

Source

Regeneron Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:29-0400

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Medical and Biotech [MESH] Definitions

Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

The amount of a substance secreted by cells or by a specific organ or organism over a given period of time; usually applies to those substances which are formed by glandular tissues and are released by them into biological fluids, e.g., secretory rate of corticosteroids by the adrenal cortex, secretory rate of gastric acid by the gastric mucosa.

Total or subtotal destruction of the pituitary gland by chemical injection. It is usually achieved by injection of ethyl alcohol via trans-sphenoidal cannulation under stereotaxic control. It is usually performed for the treatment of intractable pain.

Measurement of the maximum rate of airflow attained during a FORCED VITAL CAPACITY determination. Common abbreviations are PEFR and PFR.

Hemorrhagic necrosis that was first demonstrated in rabbits with a two-step reaction, an initial local (intradermal) or general (intravenous) injection of a priming endotoxin (ENDOTOXINS) followed by a second intravenous endotoxin injection (provoking agent) 24 h later. The acute inflammation damages the small blood vessels. The following intravascular coagulation leads to capillary and venous THROMBOSIS and NECROSIS. Shwartzman phenomenon can also occur in other species with a single injection of a provoking agent, and during infections or pregnancy. Its susceptibility depends on the status of IMMUNE SYSTEM, coagulation, FIBRINOLYSIS, and blood flow.

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