Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Phase 1 Key Inclusion Criteria * 18 to 55 years of age * Participants who are healthy as determined by medical evaluation * History of recent meningococcal, pneumococcal and Haemophilus influenzae type B vaccinations or willing to be vaccinated * Screening tests negative for illicit drug, nicotine, and alcohol use Phase 1 Key Exclusion Criteria * History of any significant medical conditions, except for completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia without evidence of recurrence within the prior 3 months * Any viral, bacterial, parasitic, or fungal infection within the prior 30 days * Frequent respiratory, nasopharyngeal or ear infections (more than 5 infections per year) * History of environmental exposure or sick contact that increase the risk of meningococcal, pneumococcal and/or Haemophilus influenza type B infections * Complement deficiency or immunodeficiency syndrome * Major surgery or significant traumatic injury within the prior 3 months * History of anaphylaxis or hypersensitivity reactions * History of penicillin allergy * History of splenectomy * History of alcohol abuse or illicit drug use * Donated plasma within the prior 7 days * Donated blood or loss more than 400 milliliters of blood (excluding blood volume drawn at screening) within the prior 90 days * Screening estimated creatinine clearance of less than 60 milliliters per minute * Screening hematology, serum chemistry, or coagulation parameters that are outs…