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A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia

Primary Outcome Measures Incidence of adverse events following administration of BBP-671 (Time Frame= 43 day) BBP-671 concentration dependent change in change from baseline in QTcF (Time Frame= 43 days) Pharmacokinetic Assessments: Cmax (Time Frame= 43 days) Time to maximum concentration (Cmax) Pharmacokinetic Assessments: Tmax (Time Frame: 43 days) Time to reach maximum observed plasma concentration (Tmax) Pharmacokinetic Assessments: t1/2 (Time Frame: 43 days) Plasma decay half-life (t1/2) Pharmacokinetic Assessments: AUC (Time Frame: 43 days) Area under the plasma concentration-time curve (AUC) Pharmacokinetic Assessments: CL/F (Time Frame= 43 day) Apparent clearance (CL/F) Pharmacokinetic Assessments: Vz/F (Time Frame= 43 days) Apparent volume of distribution (Vz/F) Pharmacokinetic Assessments: CLr (Time Frame= 43 days) Renal clearance (CLr) Secondary Outcome Measures : Food Effect: Cmax (Time Frame: 10 days) Time to maximum concentration Food Effect: Tmax (Time Frame= 10 days) Time to reach maximum observed plasma concentration Food Effect: AUC (Time Frame= 10 days) Area under the plasma concentration-time curve Pharmacodynamic Assessment: Whole blood and plasma biomarker concentrations will be quantified and summarized using appropriate descriptive parameters (Time Frame= 43 days) Measurement will be done using liquid chromatography-tandem mass spectrometry

Primary Outcome Measures Incidence of adverse events following administration of BBP-671 (Time Frame= 43 day) BBP-671 concentration dependent change in change from baseline in QTcF (Time Frame= 43 days) Pharmacokinetic Assessments: Cmax (Time Frame= 43 days) Time to maximum concentration (Cmax) Pharmacokinetic Assessments: Tmax (Time Frame: 43 days) Time to reach maximum observed plasma concentration (Tmax) Pharmacokinetic Assessments: t1/2 (Time Frame: 43 days) Plasma decay half-life (t1/2) Pharmacokinetic Assessments: AUC (Time Frame: 43 days) Area under the plasma concentration-time curve (AUC) Pharmacokinetic Assessments: CL/F (Time Frame= 43 day) Apparent clearance (CL/F) Pharmacokinetic Assessments: Vz/F (Time Frame= 43 days) Apparent volume of distribution (Vz/F) Pharmacokinetic Assessments: CLr (Time Frame= 43 days) Renal clearance (CLr) Secondary Outcome Measures : Food Effect: Cmax (Time Frame: 10 days) Time to maximum concentration Food Effect: Tmax (Time Frame= 10 days) Time to reach maximum observed plasma concentration Food Effect: AUC (Time Frame= 10 days) Area under the plasma concentration-time curve Pharmacodynamic Assessment: Whole blood and plasma biomarker concentrations will be quantified and summarized using appropriate descriptive parameters (Time Frame= 43 days) Measurement will be done using liquid chromatography-tandem mass spectrometry