Study # Test Article Formulation Route Dose (mg/kg) Dose vol. (mL/kg) Study Nature Time (hr) Study 1a [125I]Peptide A IR IV 0.5 1 PK 0, 0.083, 0.25, 0.5, 1, 2, 3, 4, 6, 24, 72 and 240 Study 2 Peptide A IR SC 2 0.4 PK 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 30 and 48 Study 3 Peptide A CR SC 2 0.4 PK 0, 0.5, 1, 2, 3, 4, 6, 24, 72 and 240 Study 4 [125I]Peptide A IR SC 2 0.4 Tissue Distribution 0, 0.5, 1, 3 and 7 Study 5 [125I]Peptide A CR SC 2 0.4 Tissue Distribution 0, 1, 6, 24, 72 and Study 6 [125I]Peptide A IR SC 2 0.4 Metabolite Profile 1, 2 and 3 Study 7 [125I]Peptide A CR SC 2 0.4 Metabolite Profile 1, 2 and 3 aN=5 for study 1, N=3 in study 2-7. Abbreviations: IR-instant release, CR-controlled release.

Table 1: Summary of in vivo Animal study designs

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