Abstract: Background – Chronic inflammatory enteropathy (CIE) is characterized by recurrent clinical signs of vomiting, diarrhea, weight loss, and decreased appetite. There are no monoclonal antibody (mAb) therapies available for treatment of CIE in veterinary medicine. VMB-C001a is a canine-specific mAb under evaluation for treatment of CIE in dogs. Hypothesis/Objective – To evaluate safety, tolerability, bioavailability, and pharmacokinetics (PK) of VMB-C001a administered IV as a single dose or SC for 3 monthly doses. Animals – 20 healthy beagles Methods – Dogs were randomized into one of 5 treatment groups as presented in Table 1. Physical examinations occurred monthly. CBC and serum chemistry were evaluated every two weeks or monthly. PK samples were collected at 0, 8, 24, 36, 48, 56 hours and on Days 3, 4, 7, 14, 21, 28 following each treatment. Results – There were no clinically significant adverse events in any treatment group. Clinical pathology parameters showed no clinically significant abnormalities or differences between treatment groups. VMB-C001a concentrations following one IV or three SC doses are presented in Figure 1. The mean 6 mg/kg IV and SC half-life was approximately 9.25 and 11.93 days, respectively. The accumulation ratio was 1.20, 1.30, and 1.50 for the 3, 6, and 18 mg/kg treatment groups. Absolute bioavailability of the 6 mg/kg SC treatment group was 89%. Conclusion and Clinical Importance – Three monthly doses of VMB-C001a were tolerated and safe at all dose levels and routes evaluated. PK results support monthly SC dosing.
