Table 1
Study designs.
Target animal safety studies | Preliminary margin-of-safety topical (Study #1) | Regulatory margin-of-safety topical (Study #2) | Regulatory oral tolerance (Study #3) |
---|---|---|---|
Investigated product(s) | Esafoxolaner 1.2% w/v, eprinomectin 0.4% w/v, praziquantel 8.3% w/v | NexGard® Combo: | |
Esafoxolaner 5.5% w/v | esafoxolaner 1.2% w/v, eprinomectin 0.4% w/v, praziquantel 8.3% w/v | ||
Study groups (number of male and female cats) | One control group (no treatment) (1 M, 1 F) | One control group (mineral oil) (4 M, 4 F) | One control group (sterile water) (4 M, 4 F) |
Three treatment groups: | Three treatment groups: | One treatment group: | |
3× (3 M, 3 F) | 1× NexGard® Combo (4 M, 4 F) | 1× NexGard® Combo (4 M, 4 F) | |
5× (3M, 4F) | 3× NexGard® Combo (4M, 4F) | ||
Esafoxolaner 103.1 mg/kg (1.875 mL/kg) (4M, 2F) | 5× NexGard® Combo (4M, 4F) | ||
Number and frequency of treatments | 3× and 5× groups: Four topical applications at 2-week intervals (i.e., Days 0, 14, 28 and 42) | Control and all treatment groups: Six topical applications at 4 week intervals (i.e., Days 0, 28, 56, 84, 112 and 140) | Control and the treatment group: single oral administration on Day 0 |
Esafoxolaner group: Two topical applications at 4-week intervals (i.e., Days 0 and 28) | |||
Study variables | Clinical reactions, bodyweight, clinical pathology, anatomical pathology | Clinical reactions, bodyweight, food and water consumption, clinical pathology, anatomical pathology | Clinical reactions, bodyweight, food and water consumption, clinical pathology |
Age of cats at study start | 8–10 weeks | 8–9 weeks | 7–9 weeks |
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