A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis

Exclusion Criteria

• •1. Have a clinically significant medical history or surgical history and have at least one of the following findings:
• •1. Have skin diseases that may affect the absorption of the IP (eg, psoriasis, contact dermatitis), scars, tattoos, and skin abnormalities that may interfere with SC injections, or a history of surgery within 60 days of Screening (except for simple appendectomy or hernia repair, as assessed by the PI or designee).
• •2. Have a recent significant history of kidney diseases, pancreatitis and/ or nephrolithiasis.
• •3. Participants with liver cirrhosis accompanying edema and/or ascites.
• •4. Have known clinically significant allergies as assessed by the PI or designee, diseases of either/or the cardiovascular system, peripheral vascular system, skin, mucous membranes, eyes, respiratory system, musculoskeletal system, and/or any other diseases that may pose a problem with the PK evaluation. History of childhood asthma can be included at the discretion of the PI or designee.
• •5. Presence of any underlying physical, or psychological medical condition that, in the opinion of the PI or designee, will make it unlikely that the participant will comply with the protocol, or complete the study per the protocol.
• •2. Pregnant or lactating at Screening or planning to become pregnant at any time during the study, including the follow-up period.
• •3. Have a clinically relevant history of hypersensitivity reactions or allergic reactions to drugs (such as aspirin and antibiotics), or known drug allergies (eg, to aspirin, nonsteroidal anti-inflammatory drugs \[NSAIDs\], antibiotics, iodine, anesthetics, other monoclonal antibodies, etc.).
• •4. Participants who have donated whole blood within 60 days prior to Screening or blood components within 30 days or received blood transfusion within 60 days.
• •5. Have received an IP or bioequivalence IP in another clinical study or bioequivalence study within 30 days prior to Screening or five half-lives prior to Screening.
• •6. Use of any prescription drugs within 14 days prior to dosing or non-prescription medications/products, including vitamins, minerals, and phyto-therapeutic/herbal/plant-derived preparations, alternative medicines, or dietary supplements within 7days prior to dosing (at the discretion of the PI or designee). The occasional use of paracetamol(up to 2g/day) is permitted.
• •7. History of alcoholism, substance or drug abuse-related disorders deemed significant by the PI or designee.
• •8. Participants with a positive toxicology screening panel. Positive test may be repeated once at the discretion of the investigator.
• •9. Have positive serology test (hepatitis B surface antigen \[HBsAg\], or hepatitis C virus antibody \[anti-HCV\], human immunodeficiency virus \[HIV\] test,) at Screening.
• •10. Active infection requiring medical treatment and/or isolation at the time of Screening.
• •11. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) \> 2.0 × upper limit of normal (ULN).
• •12. Bilirubin \> 1.5 × ULN (isolated bilirubin \> 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%).
• •13. QTcF \> 450 msec for male participants or QTcF \> 470 msec for female participants. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF).
• •14. Participants with corrected calcium (Ca) \> ULN, uric acid \> ULN, and/or estimated glomerular filtration rate \< 90 mL/min, calculated using Cockroft Gault formula.
• •15. Others who are ineligible to participate in this clinical study as determined by the PI or designee.