Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis

Exclusion Criteria

• •Clinically significant manifestation of metabolic; hepatic; renal; haematological; pulmonary; cardiovascular; gastrointestinal; musculoskeletal; dermatological; urogenital; eye, ear, nose, and throat; psychiatric; or neurological disorders.
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.2 times the upper limit of normal (ULN) as defined by the laboratory.
• •Positive hepatitis panel (hepatitis B surface antigen \[HBsAg\] and anti-hepatitis C virus \[HCV\]) or positive human immunodeficiency virus (HIV) antibody.
• •Positive Quantiferon tuberculosis (TB) test at Screening Visit.
• •Receipt of live vaccine less than 1 month prior to Check in or plan to receive live vaccine during the study or up to 3 months following End of Treatment visit.
• •Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral antibiotics.
• •Psoriasis Patients (Expansion Cohort):
• •History of malignancy, diagnosed or known to be active or actively treated within the past 5 years, other than resected lesions of low malignant potential, such as basal cell skin cancers or low risk squamous cell carcinomas of the skin.
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of normal (ULN) as defined by the laboratory.
• •Creatinine \> 1.5 times ULN as defined by the laboratory.
• •Positive hepatitis panel (hepatitis B surface antigen \[HBsAg\] and anti-hepatitis C virus \[HCV\]) or positive human immunodeficiency virus (HIV) antibody.
• •Positive Quantiferon tuberculosis (TB) test at Screening Visit.
• •Receipt of live vaccine less than 1 month prior to Check in or plan to receive live vaccine during the study or up to 3 months following End of Treatment visit.
• •Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral antibiotics.
• •Use of a prescription medication that could have an effect on psoriasis (eg, lithium, systemic steroids, immunosuppressants) during the 14 days before Check-in; use of prescription medications for psoriasis is not permitted until after the Follow-up Visit.
• •Non plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular).
• •Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab, ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB) phototherapy, use of tanning beds, or use of systemic medications such as methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Check-in.
• •Ulcerative Colitis Patients (Expansion Cohort):
• •Ulcerative colitis requiring immediate surgical, endoscopic, or radiological intervention including massive haemorrhage, perforation and sepsis, suppurative complications, or toxic colon.
• •Stool positive for Clostridium difficile toxin, enteric pathogens, or ova and parasites.
• •Positive hepatitis panel (hepatitis B surface antigen \[HBsAg\] and anti hepatitis C virus \[HCV\]) or positive human immunodeficiency virus (HIV) antibody.
• •Positive Quantiferon tuberculosis (TB) test at Screening Visit.
• •Receipt of live vaccine less than 1 month prior to Check in or plan to receive live vaccine during the study or up to 3 months following End of Treatment visit.
• •Infection in the 4 weeks prior to Check-in that required hospitalization or parenteral antibiotics.
• •Use of biologic agents (eg, adalimumab, etanercept, infliximab, ustekinumab, ixekizumab, secukinumab, guselkumab, tildrakizumab, brodalumab) or psoralen and ultraviolet A (PUVA) within 12 weeks prior to Check-in, ultraviolet B (UVB) phototherapy, use of tanning beds, or use of systemic medications such as methotrexate, cyclosporine A, acitretin, tofacitinib or apremilast within 4 weeks prior to Check-in, or topical anti-psoriasis medications (except emollients) within 2 weeks prior to Check-in.