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

Inclusion Criteria Male and female adults 18 to 55 years old Body mass index (BMI) between 18 and 32 kg/m2 Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Willing and able to provide informed consent and comply with all study visits and procedures Negative urine drug, nicotine/tobacco, and breath alcohol test result Neisseria meningitis vaccination Pneumococcus vaccination Hemophilus influenzae vaccination Exclusion Criteria Any significant medical history Active malignancy and/or history of malignancy in the past 5 years History of liver disease, Gilbert's syndrome, or abnormal liver function test Estimated creatinine clearance <60 mL/min using the Cockcroft-Gault formula Any active infection or acute illness History of meningococcal infection or frequent respiratory, nasopharyngeal or ear infections History of previous or current tuberculosis infection. Prior splenectomy Major surgery or significant traumatic injury occurring within 3 months Have any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion Positive serology tests for human immunodeficiency virus hepatitis B surface antigen or hepatitis C virus Use of any prescription, vaccines, supplements/vitamins, or over-the counter medication Treatment with another investigational product within 30 days Known any clinically significant allergic reactions Known hypersensitivity to any of the study drug ingredients or penicillin. History or presence of alcohol Blood donation Pregnancy May have a higher risk to be exposed to infected individuals, for example active healthcare employees. Criteria (Part B) Inclusion Criteria Male and female adults 18-65 years old Confirmed diagnosis of PNH based on documented clone size of PNH blood cells by flow cytometry. Serum LDH levels are at least 1.25-fold above the ULN for non-treated participants Liver function test values are less than 2x ULN Mean hemoglobin (Hb) <12 g/dL. A history of red blood cell transfusion within at least 3 months Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening. Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Willing and able to provide informed consent and comply with all study visits and procedures Neisseria meningitis vaccination Pneumococcus vaccination Hemophilus influenzae vaccination Exclusion Criteria Known or suspected hereditary or acquired complement deficiency History of clinically significant arterial or venous thrombosis History of hematopoietic stem cell transplantation History of meningococcal infection Any significant medical history Active malignancy and/or history of malignancy in the past 5 years Any active viral, bacterial, parasitic, or fungal infection or acute illness Any evidence of sero-positive autoimmune connective tissue diseases Any evidence of active inflammatory conditions History of previous or current tuberculosis infection. Prior splenectomy Major surgery or significant traumatic injury occurring within 3 months Have any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion Inadequate organ function Positive serology tests for human immunodeficiency virus hepatitis B surface antigen or hepatitis C virus Willing to continue after enrollment with their current treatment with a complement inhibitor. Use of vaccines, or changes in any prescription, supplements/vitamins, or over-the counter medication Treatment with another investigational product or biologic agent within 30 days Blood donation within 30 days Pregnancy