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Atlas/Monoclonal antibodies/Anthim/First dose

Anthim: how was the first human dose set?

obiltoxaximab · B. anthracis PA
Check my plan vs. these
First-in-human starting dose
Single-dose clinical escalation supported by monkey AUC margin: 10 mg/kg AUC ~50,000 µg·hr/mL vs human AUC 10,000 at 114 mg
“The 10 mg/kg dose to monkeys with an approximate AUC of 50,000 µg·hr/ml provides an appropriate margin of safety based upon the human AUC of 10,000 following a 114 mg dose of Anthim.”
✓ VerifiedFDA pharmacology/toxicology review, p. 53Source ↗
NOAEL / key findings
NOAEL 30 mg/kg (highest dose) in definitive rat study; no test article-related toxicity; MTD not reached
“The NOAEL was the high dose, 30 mg/kg, for both the Lonza and Baxter material”
✓ VerifiedFDA pharmacology/toxicology review, p. 101Source ↗

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Summary across all 117 monoclonal antibodies →