To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects

Inclusion Criteria:

1. Healthy male or female subjects, between the age of 18 and 55 years, both inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailedmedical history, full physical examination, including blood pressure and heart ratemeasurement, 12-lead ECG, and clinical laboratory tests prior to administration ofthe study drug).

2. Subject is informed and able to understand the full nature and purpose of the study,including possible risks and side effects, and is given ample time and opportunityto read and understand this information. Subject has the ability and agrees tocooperate with the Investigator and must sign and date the written informed consentprior to performing any of the screening procedures.

3. BMI between 18.0 and 32.0 kg/m2, both inclusive.

4. Subject and their partner of childbearing potential must agree to use a highlyeffective method of contraception throughout the study and for 5 months after theadministration of assigned treatment. A man is of childbearing potential if, in theopinion of the Investigator, he is sexually active. Male and female subjects andtheir partners who have been surgically sterilised for less than 24 weeks prior tothe date of informed consent must agree to use any medically acceptable methods ofcontraception. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearingpotential

Exclusion Criteria:

1. Subject has a medical history and/or condition including one or more of thefollowing disease(s):

• History and/or current presence of clinically significant atopy (e.g., allergicasthma, eczematous dermatitis), known or suspected clinically relevanthypersensitivity or allergic reactions to any of the excipients of study drug,other murine and human proteins, or Ig products.

• Known infection with hepatitis B (active or carrier of hepatitis B), hepatitisC, or human immunodeficiency virus (HIV). However, a subject with history ofhepatitis B virus is allowed if resolved.

• History of invasive systemic fungal infections (including histoplasmosis,coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, andpneumocystosis, etc.) or other opportunistic infections judged by theInvestigator, including local fungal infections or a history of herpes zoster.

• History of and/or current cardiac (including New York Heart Association classIII/IV heart failure), gastrointestinal, renal, endocrine, neurologic,autoimmune, hepatic haematological (including pancytopenia, aplastic anaemia,or blood dyscrasia, etc.), metabolic (including diabetes mellitus), orpulmonary disease classed as significant by the Investigator.

• History of any malignancy.

• Systemic or local infection, such as the risk of sepsis and/or known activeinflammation within 2 months before screening.

• Severe infections requiring hospitalisation and/or the need for IV antibiotics,within 2 months before screening.

2. A sign of ongoing or chronic inflammation process defined as high bloodconcentration of C-reactive protein (CRP) (> 1.5 times the upper limit of normal [ULN]).

3. Subject has inadequate liver function as determined by following results:

• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 1.5 × ULN and

• Total bilirubin > 1.5 × ULN.

4. Subject is considered to have a significant abnormal cardiac function inInvestigator's discretion determined by the laboratory results.

5. Subject underwent surgical intervention or an operation within 4 weeks prior to theadministration of the study drug (Day 1) or plans to undergo a surgical procedureduring the study period.

6. Subject has active TB, latent TB (defined as a positive result for IGRA with noactive lesion in examination of chest X-ray without any sign or symptom of TB), ahistory of TB, or had close contact with a person with active TB within 8 weeksprior to the administration of the study drug (Day 1). If the result of IGRA isindeterminate at screening, retest will be allowed only once during the screeningperiod. If the repeated IGRA result is again indeterminate or positive, the subjectwill be excluded from the study. If the repeated IGRA result is negative, thesubject may be included in the study.

7. Female subject is pregnant or lactating or planning to be pregnant or to breastfeedbefore, during, or within 5 months after the administration of the study drug (Day 1).

8. Male subject is planning to father a child or donate sperms within 5 months afterthe administration of the study drug (Day 1).

9. Subject has received a mAb or fusion protein within 9 months prior to randomizationand/or there is a confirmed evidence or clinical suspicion of immunogenicity fromprevious exposure to a mAb or fusion protein, or subject is currently using abiologic (including but not limited to TNF-α blockers). Subjects with previousexposure to adalimumab are to be excluded.

10. Subject has received treatment with a biological or immunosuppressive agent (otherthan a mAb or fusion protein) within 3 months of screening.

11. Subject used prescription (excluding hormonal birth control), over the counter (OTC)drugs, dietary supplements, or herbal remedies that could affect the outcome of thestudy within 2 weeks prior to the administration of the study drug (Day 1).

12. Subject has undergone treatment with an investigational drug or participated inanother clinical study for healthy subject or bioequivalence test within 90 days or 5 half-lives (whichever is longer) prior to the administration of the study drug (Day 1) or plan to do so during the study.

13. Subject received a live or live-attenuated vaccine within 4 weeks prior to theadministration of the study drug (Day 1) or plan to do so until 6 months after Day

15. Subject has donated or lost 450 mL or more of whole blood within 8 weeks, or donatedblood components within 4 weeks prior to the administration of the study drug (Day 1).

16. Subject shows reasonable evidence of drug abuse (positive result for drug urine testand/or the opinion of the Investigator).

17. Subject has a history or presence of regular consumption exceeding an average weeklyintake of 21 units of alcohol in recent 12 weeks prior to the screening visit. Oneunit is equivalent to a half-pint (285 mL) of beer/lager, one measure (25 mL) ofspirits, or one small glass (125 mL) of wine. Subject is unwilling to avoid use ofalcohol or alcohol containing foods, medications, or beverages within 24 hours priorto admission (Day -1), and each study visit until completion of the study.

18. Subject has smoked 10 or more cigarettes per day in the recent 12 weeks prior to theadministration of the study drug (Day 1) and/or is unable to refrain from smoking upto 24 hours after the administration of the study drug.

19. In the opinion of the Investigator, the subject is not eligible for the studyparticipation for any reason (including clinical laboratory results) or showsevidence of a condition (e.g., psychological, or emotional problem, any disorder orresultant therapy) that is likely to invalidate an informed consent or limit theability of the subject to comply with the protocol requirements. Subject is unableto understand the protocol requirements, instructions, study-related restrictions,or the nature, scope, and possible consequences of the clinical study; or is unableto give written informed consent or to comply fully with the protocol.

20. Subject with confirmed COVID-19 infection by appropriate laboratory test screeningand on admission.

21. Subject is vulnerable (e.g., employees of the study centre or any other individualsinvolved with the conduct of the study, or immediate family members of suchindividuals, persons kept in prison, or other institutionalised persons by lawenforcement).