This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be evaluated in healthy volunteers (HV) during part 1. The safety, tolerability, PK and PD of multiple doses of crovalimab will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) in parts 2, 3, 4, and OLE of the study. Efficacy of crovalimab will be evaluated in Parts 2, 3, and 4.
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Part 1: Percentage of Participants With Dose-Limiting Events (DLEs)
Timeframe: Baseline up to approximately 3 months
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Baseline up to approximately 3 months
Part 2: Percentage of Participants With AEs and SAEs
Timeframe: Baseline up to approximately 8 months
Part 3: Percentage of Participants With AEs and SAEs
Timeframe: Baseline up to approximately 8 months
Part 4: Percentage of Participants With AEs and SAEs
Timeframe: Baseline up to approximately 8 months
Part 2: Terminal Complement Activity in Serum as Assessed by Ex Vivo Liposome Immunoassay (LIA)
Timeframe: Baseline up to Day 224
Part 3: Terminal Complement Activity as Assessed by Ex Vivo Liposome Lysis in Serum Using the LIA
Timeframe: Baseline up to Day 224
Part 4: Terminal Complement Activity in Serum as Assessed by Ex Vivo Liposome Immunoassay (LIA)
Timeframe: Baseline up to Day 224
OLE: Percentage of Participants With AEs and SAEs
Timeframe: OLE: Week 21 up to Week 567