Safety, pharmacokinetic, and pharmacodynamic evaluations of PI-2301, a potent immunomodulator, in a first-in-human, single-ascending-dose study in healthy volunteers

Journal of Clinical Pharmacology

Volumn 51, Issue 5, 2011, Pages 649-660

  Kovalchin, Joseph ^a   Krieger, Jeffrey ^a   Collins, Kathy ^a   Genova, Michelle ^a   Augustyniak, Michael ^a   Masci, Allyson ^a   Avril, Tony ^b   Gandon, Gwenola ^b   Patat, Alain ^c   Fauchoux, Nicolas ^c   Toutin, Claire ^d   Lacoste, Eric ^d   Patel, Uday ^a   Mascioli, Edward ^a   Zanelli, Eric ^a  

^a Peptimmune Inc   (United States)

^b CENTRE EUGÈNE MARQUIS   (France)

^c Biotrial   (France)

^d Avogadro ^*  (France)

Author keywords

biomarkers; Copolymers; immunomodulatory; multiple sclerosis; YFAK

Indexed keywords

CD16 ANTIGEN; CD19 ANTIGEN; CD4 ANTIGEN; CD56 ANTIGEN; CD8 ANTIGEN; CXCL9 CHEMOKINE; GAMMA INTERFERON; GAMMA INTERFERON INDUCIBLE PROTEIN 10; IMMUNOMODULATING AGENT; INTERLEUKIN 10; INTERLEUKIN 13; INTERLEUKIN 2; INTERLEUKIN 6; INTERLEUKIN 8; MACROPHAGE DERIVED CHEMOKINE; PI 2301; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CELL PROLIFERATION; CONTROLLED STUDY; CYST; DOSE CALCULATION; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG ERUPTION; DRUG SAFETY; ERYTHEMA; HUMAN; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; ORTHOSTATIC HYPOTENSION; PAIN; PHARMACODYNAMICS; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SKIN INDURATION; T LYMPHOCYTE;

ADOLESCENT; ADULT; AGED; ANTIBODIES; BIOLOGICAL MARKERS; CELL PROLIFERATION; CELLS, CULTURED; CHEMOKINE CXCL10; CHEMOKINE CXCL9; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FRANCE; HUMANS; IMMUNOLOGIC FACTORS; INJECTIONS, SUBCUTANEOUS; INTERFERON-GAMMA; INTERLEUKIN-13; LYMPHOCYTE ACTIVATION; MALE; MIDDLE AGED; OLIGOPEPTIDES; POLYMERS; PROTEINS; T-LYMPHOCYTES; YOUNG ADULT;

EID: 79955537385     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010373930     Document Type: Article

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