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

Inclusion Criteria:

1. Healthy males and females, between 18 to 60 years inclusive, at the time ofScreening.

2. Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2(inclusive), at Screening,with a minimum body weight of 50 kg

3. In good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs measurement, and clinical laboratory evaluations atScreening, as assessed by the PI or designee.

4. All female participants of childbearing potential with male sexual partners and maleparticipants with female sexual partners of childbearing potential must consent touse two highly effective methods of contraception from start of study and for atleast 90 days (male and female participants) following the EOS visit or last dose ofstudy treatment, whichever is later. Male participants must refrain from spermdonation from start of study and for 90 days after last dose of IP; femaleparticipants must refrain from donation of ova from start of study and for 30 daysafter last dose of IP. WOCBP must have a negative serum pregnancy test at Screeningand a negative urine pregnancy test on Screening, and be willing to undergoadditional pregnancy tests, as required, throughout the study. Women not ofchildbearing potential must be postmenopausal (defined as cessation of regularmenstrual periods for at least 12 months without an alternative medical cause),confirmed by follicle-stimulating hormone (FSH) level >40 IU/mL at Screening.

5. Participants whose smoking habit in the last 3 months prior to Screening included nomore than 14 cigarettes per week (includes e-cigarettes and other nicotine andtobacco products) can be included in the study but must be willing to abstain fromsmoking from Screening until completion of the EOS visit (Part A only).

6. Ability and willingness to restrict the use of alcohol to ≤ 21 units per week formales and ≤ 14 units per week for females. One unit of alcohol equals ½ pint (285mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.Participants must have negative alcohol breath tests at Screening and Day -1 visits.

7. Participants who are able to receive SC injections specifically participants whohave scars or tattoos in the area of concern.

8. Participants must participate voluntarily, sign the ICF, have good compliance, beable and willing to attend the necessary site visits and be willing to cooperatewith follow-up visits.

9. No history of severe allergic or anaphylactic reactions, including known allergiesor hypersensitivities to NP-201 acetate or its excipients.

Exclusion Criteria:

1. Have a clinically significant medical history or surgical history and have at leastone of the following findings:

2. Have skin diseases that may affect the absorption of the IP (eg, psoriasis,contact dermatitis), scars, tattoos, and skin abnormalities that may interferewith SC injections, or a history of surgery within 60 days of Screening (exceptfor simple appendectomy or hernia repair, as assessed by the PI or designee).

3. Have a recent significant history of kidney diseases, pancreatitis and/ ornephrolithiasis.

4. Participants with liver cirrhosis accompanying edema and/or ascites.

5. 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 ordesignee.

6. Presence of any underlying physical, or psychological medical condition that,in the opinion of the PI or designee, will make it unlikely that theparticipant will comply with the protocol, or complete the study per theprotocol.

7. Pregnant or lactating at Screening or planning to become pregnant at any time duringthe study, including the follow-up period.

8. Have a clinically relevant history of hypersensitivity reactions or allergicreactions 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.).

9. Participants who have donated whole blood within 60 days prior to Screening or bloodcomponents within 30 days or received blood transfusion within 60 days.

10. Have received an IP or bioequivalence IP in another clinical study or bioequivalencestudy within 30 days prior to Screening or five half-lives prior to Screening.

11. Use of any prescription drugs within 14 days prior to dosing or non-prescriptionmedications/products, including vitamins, minerals, andphyto-therapeutic/herbal/plant-derived preparations, alternative medicines, ordietary supplements within 7days prior to dosing (at the discretion of the PI ordesignee). The occasional use of paracetamol(up to 2g/day) is permitted.

12. History of alcoholism, substance or drug abuse-related disorders deemed significantby the PI or designee.

13. Participants with a positive toxicology screening panel. Positive test may berepeated once at the discretion of the investigator.

14. Have positive serology test (hepatitis B surface antigen [HBsAg], or hepatitis Cvirus antibody [anti-HCV], human immunodeficiency virus [HIV] test,) at Screening.

15. Active infection requiring medical treatment and/or isolation at the time ofScreening.

16. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) > 2.0 × upper limit of normal (ULN).

17. Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin isfractionated and direct bilirubin < 35%).

18. 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'sformula (QTcF).

19. Participants with corrected calcium (Ca) > ULN, uric acid > ULN, and/or estimatedglomerular filtration rate < 90 mL/min, calculated using Cockroft Gault formula.

20. Others who are ineligible to participate in this clinical study as determined by thePI or designee.