Phase I Study of a Human Monoclonal Antibody Directed against the CD4-Binding Site of HIV Type 1 Glycoprotein 120

1998 ◽  
Vol 14 (7) ◽  
pp. 545-550 ◽  
Author(s):  
LISA A. CAVACINI ◽  
MATTHEW H. SAMORE ◽  
JOHN GAMBERTOGLIO ◽  
BROOKS JACKSON ◽  
MARK DUVAL ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Phase I ◽  
Binding Site ◽  
Phase I Study ◽  
Human Monoclonal Antibody ◽  
Cd4 Binding Site ◽  
Hiv Type 1

Phase I study of CNTO 95, a fully human monoclonal antibody (mAb) to αv integrins, in patients with solid tumors

2004 ◽  
Vol 22 (14_suppl) ◽  
pp. 3119-3119 ◽  
Author(s):  
G. C. Jayson ◽  
S. Mullamitha ◽  
C. Ton ◽  
J. Valle ◽  
M. Saunders ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Phase I ◽  
Solid Tumors ◽  
Phase I Study ◽  
Human Monoclonal Antibody

Phase I study of CNTO 95, a fully human monoclonal antibody (mAb) to αv integrins, in patients with solid tumors

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 3113-3113 ◽  
Author(s):  
G. C. Jayson ◽  
S. Mullamitha ◽  
C. Ton ◽  
J. Valle ◽  
A. Jackson ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Phase I ◽  
Solid Tumors ◽  
Phase I Study ◽  
Human Monoclonal Antibody

A Human Monoclonal Antibody Specific for the V3 Loop of HIV Type 1 Clade E Cross-Reacts with Other HIV Type 1 Clades

1998 ◽  
Vol 14 (3) ◽  
pp. 213-221 ◽  
Author(s):  
MIROSLAW K. GORNY ◽  
JOHN R. MASCOLA ◽  
ZIMRA R. ISRAEL ◽  
THOMAS C. VanCOTT ◽  
CONSTANCE WILLIAMS ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Human Monoclonal Antibody ◽  
V3 Loop ◽  
Hiv Type 1

scholarly journals Phase I Study Evaluating the Safety and Pharmacokinetics of MDX-1303, a Fully Human Monoclonal Antibody against Bacillus anthracis Protective Antigen, in Healthy Volunteers

2011 ◽  
Vol 18 (12) ◽  
pp. 2136-2142 ◽  
Author(s):  
Valerie Riddle ◽  
Phillip Leese ◽  
Diann Blanset ◽  
Melany Adamcio ◽  
Matthew Meldorf ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Adverse Events ◽  
Phase I ◽  
Bacillus Anthracis ◽  
Phase I Study ◽  
Protective Antigen ◽  
Human Monoclonal Antibody ◽  
Systemic Exposure ◽  
Healthy Human ◽  
Serious Adverse Events

ABSTRACTMDX-1303 (Valortim) is a fully human monoclonal antibody (hMAb) with a high affinity forBacillus anthracisprotective antigen (PA). MDX-1303 binds to PA and interferes with the activity of the anthrax toxin; it was selected based on its superior functional activity in the toxin neutralization activity (TNA) assay. MDX-1303 has demonstrated efficacy in the postexposure and therapeutic settings in New Zealand White rabbits, cynomolgus monkeys, and African green monkeys. This phase I study sought to characterize the safety, tolerability, immunogenicity, and pharmacokinetics (PK)/pharmacodynamics (PD) of MDX-1303 in healthy human subjects. Cohorts of 3 to 10 subjects were administered MDX-1303 as either a single intravenous (i.v.) dose at dose levels of 0.3, 1, 3, 10, and 20 mg/kg of body weight or as a single intramuscular (i.m.) dose at 100 mg. Forty-six subjects were enrolled, and 16 (35%) of these subjects experienced one or more grade 1 adverse events considered to be related to treatment with MDX-1303. There were no grade 2 to 4 adverse events or serious adverse events (SAEs) considered to be related to treatment. The mean half-life of MDX-1303 ranged from 22 to 33 days across the i.v. administration cohorts and was approximately 32 days following i.m. administration. Systemic exposure following 100-mg i.m. administration was within the range of exposure following 1-mg/kg i.v. administration with a relative bioavailability of approximately 65%. MDX-1303 was generally well tolerated, and no anti-MDX-1303 antibodies were detected following a single dose.

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