Safety, tolerability and pharmacokinetics of a human anti-IL-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study.

van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ.
Journal   Br J Clin Pharmacol.
Analytes Measured   RANTES
Matrix Tested  
Year   2012
Page Numbers  
Application   Cytokines and Chemokines
AIMS: Assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of CNTO 5825 following single-dose IV and subcutaneous (SC) administration in healthy and healthy atopic subjects.

METHODS: Sixty-four subjects received a single dose of placebo or CNTO 5825 (0.1, 0.3, 1.0, 3.0, or 10 mg/kg IV in a dose-escalating manner, or 3.0 mg/kg SC in healthy subjects; and 10 mg/kg IV in healthy atopic subjects). Subjects were observed for 96 hours post-administration and followed for 16 weeks. Safety and tolerability were monitored and serum samples were collected to measure CNTO 5825 concentrations, antibodies to CNTO 5825, and PD biomarkers.

RESULTS: Most adverse events (AEs) were mild-to-moderate in severity and considered unrelated to CNTO 5825 with no dose dependent trends seen. The two serious AEs were considered unrelated to CNTO 5825. After IV administration, CNTO 5825 exhibited linear PK with terminal t1/2 of ∼22-32 days. After a single 3 mg/kg SC dose in healthy subjects, CNTO 5825 was absorbed into the systemic circulation with median tmax of 5.45 days and absolute bioavailability of ∼75%. The PK profile of CNTO 5825 at 10 mg/kg was similar in both healthy and healthy atopic subjects. No antibodies to CNTO 5825 were detected through week 16. In the CNTO 5825-treated healthy atopic subjects, there was a significant reduction in serum IgE and CCL17 (p = 0.028 and 0.068 vs placebo, respectively).

CONCLUSIONS: CNTO 5825 was well tolerated, had an acceptable safety profile, exhibited linear PK characteristics and no antibodies to CNTO 5825 were detected.

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