Document Detail

Pre- and postnatal development in the cynomolgus monkey following administration of ABT-874, a human anti-IL-12/23p40 monoclonal antibody.
MedLine Citation:
PMID:  23212752     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: ABT-874 is an anti-IL-12/23 monoclonal antibody that binds to the p40 subunit of human IL-12 and IL-23. As part of its preclinical safety assessment, studies were conducted to assess its potential effects on pre- and postnatal development in cynomolgus monkeys.
METHODS: In the embryo-fetal development studies, ABT-874 was administered once weekly subcutaneously to adult female cynomolgus monkeys at doses of 0, 5, 25, or 100 mg/kg during gestation days (GD) 20 to 48. Fetuses were examined for external, visceral, and skeletal development on GD 100 or 150. In the pre- and postnatal study, ABT-874 was administered once weekly subcutaneously to adult female cynomolgus monkeys at doses of 10, 50, or 200 mg/kg from GD 20 through postpartum day 182. Infants were examined from birth up to 9 months of age for morphological and functional development. Potential effects on the infant immune system were evaluated by immunophenotyping of peripheral blood lymphocytes and by T-dependent antibody response to KLH.
RESULTS: There was no ABT-874-related maternal toxicity or adverse effects on fetuses or infants. ABT-874 was present in maternal and fetal serum at GD 100 and 150, and in infant serum through day 63 postbirth. ABT-874 was also present at low levels in breast milk through postpartum day 175.
CONCLUSIONS: Exposure of cynomolgus monkey fetuses and infants to ABT-874 had no adverse effects on embryo-fetal or postnatal development.
Brian P Enright; Belen Tornesi; Gerhard F Weinbauer; Guenter Blaich
Publication Detail:
Type:  Journal Article     Date:  2012-12-04
Journal Detail:
Title:  Birth defects research. Part B, Developmental and reproductive toxicology     Volume:  95     ISSN:  1542-9741     ISO Abbreviation:  Birth Defects Res. B Dev. Reprod. Toxicol.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-10     Completed Date:  2013-05-14     Revised Date:  2013-11-14    
Medline Journal Info:
Nlm Unique ID:  101155115     Medline TA:  Birth Defects Res B Dev Reprod Toxicol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  431-43     Citation Subset:  IM    
Copyright Information:
© 2012 Wiley Periodicals, Inc.
Abbott Laboratories, Abbott Park, Illinois 60064, USA.
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MeSH Terms
Animals, Newborn
Antibodies, Monoclonal / toxicity*
Antibody Formation / drug effects
Body Weight / drug effects
Dose-Response Relationship, Drug
Embryo, Mammalian / drug effects*
Embryonic Development / drug effects*
Fetal Development / drug effects*
Hemocyanin / pharmacology
Immune System / drug effects
Injections, Subcutaneous
Lactation / drug effects
Lymphocytes / drug effects
Macaca fascicularis / physiology*
Maternal Exposure / adverse effects*
Prenatal Exposure Delayed Effects / chemically induced
Toxicity Tests
Reg. No./Substance:
0/ABT-874 antibody, human; 0/Antibodies, Monoclonal; 9013-72-3/Hemocyanin; FV4Y0JO2CX/keyhole-limpet hemocyanin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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