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. 2020 Mar 28;40(5):433–447. doi: 10.1007/s40261-020-00903-9
The mean BC 007 area under the concentration–time curves (AUC(0–t) and AUCinf) increased linearly with the dose. The plasma half-life time was fast and ranged from 3.0 min at 15 mg in the young population up to 11 min at 1900 mg BC 007 in the elderly population.
No treatment emergent adverse events (TEAEs) leading to subject discontinuation, no severe TEAEs, no serious adverse events (SAEs) and no deaths were reported throughout the entire clinical Phase I. The most common reported adverse event was a slight-to-moderate increase of the anticoagulatory effect accompanying the infusion beginning at a dose of 50 mg which normalised quickly within minutes after infusion end.
BC 007, a new drug candidate for heart failure treatment, with innovative mode of action neutralised autoantibodies against G-protein-coupled receptors in elderly healthy G-protein-coupled receptor autoantibody-positive participants. The neutralisation lasted, in most cases, for the entire observation period of 1 month.