Ixekizumab biosimilar SB35 vs Taltz: a single-dose PK and safety check in healthy adults

Inclusion Criteria:

1. Healthy male or female, aged 19-55 years (inclusive) on the day of signing the informed consent form (ICF).
2. Have a body weight between 55.0-90.0 kg (inclusive) and a body mass index (BMI) between 20.0-29.9 kg/m2 (inclusive) at Screening and Day -1.
3. Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
4. Have vital sign results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
5. Have physical examination results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
6. Female participants who are not pregnant or nursing at Screening and Day -1, and participants who are not planning to become pregnant during study period or until 10 weeks after the IP administration, whichever is longer.
7. Female participants of non-childbearing potential, defined as one of the following:

   1. Postmenopausal (defined as natural \[spontaneous\] amenorrhoea of at least 12 months without an alternative medical cause at Screening).

      Note: Participants must have follicle-stimulating hormone (FSH) level of \> 40 international units per litre (IU/L) during the screening period to confirm menopause.
   2. Those with history of hysterectomy or surgical removal of both ovaries. Documentation of surgical procedure performed at least 90 days prior to Screening or documentation of physical examination is required for confirmation of surgical sterilization OR Female participants of childbearing potential or male participants with their (respectively male or childbearing potential female) partners who agree to use a single method of highly effective birth control method, or use at least two forms of acceptable contraception method (according to the Clinical Trials Facilitation and Coordination Group \[CTFG\] Guidance) from Screening until 10 weeks after the IP administration. Vasectomy alone will be allowed for male participants and female participants of childbearing potential with a sole vasectomised male partner. Vasectomised participants or partners should be medically confirmed for sterilisation. True abstinence alone will be allowed if this is in line with the preferred and usual lifestyle of the participant, or for participants who do not have a partner. Contraceptive methods do not apply for participants whose partner is on the same gender.
8. Willing and able to comply with the scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifecycle considerations.
9. Provision of signed and dated written informed consent, which must be obtained prior to any study-related procedures being performed.

Exclusion Criteria:

1. Have a history and/or current presence of clinically significant atopic allergy, hypersensitivity, or allergic reactions (either spontaneous or following drug administration), also including known or suspected clinically relevant drug hypersensitivity to ixekizumab or to any of the excipients.
2. Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, neurologic (including reversible posterior leukoencephalopathy syndrome), metabolic (including known diabetes mellitus), psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies.
3. Have a history of inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), or signs of symptoms indicative of Crohn's disease or ulcerative colitis (based on Investigator determination), or knowledge of a family history of IBD in first degree relatives.
4. Have a history of significant respiratory disorder (including asthma and non-infectious pneumonia).
5. Have a history of malignancy (including lymphoma, leukaemia, and skin cancer).
6. Have either active or latent tuberculosis (TB) as indicated by a positive test result for Mycobacterium tuberculosis at Screening or who have a history of TB.
7. Have a history of serious infection (associated with hospitalisation and/or which required intravenous \[IV\] antibiotics) within 8 weeks prior to Randomisation.
8. Have a history of sepsis (defined as a life-threatening organ dysfunction caused by infection), invasive systemic fungal infections (e.g., histoplasmosis), other opportunistic infections, or chronic or recurrent infections judged relevant by the Investigator.
9. Have a clinically significant active infection (bacterial, viral, or fungal) within 28 days prior to Randomisation.
10. Have or have had a herpes zoster infection within 12 weeks prior to Randomisation.
11. Have previously been exposed to ixekizumab (Taltz and/or its biosimilar).
12. Have previously been exposed to a monoclonal antibody (mAb) or fusion protein within 180 days (other than ixekizumab) prior to Randomisation and/or there is confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a mAb or fusion protein.
13. Have previously been exposed to an immunosuppressive agent or biological agent (any other than a mAb or fusion protein) within 120 days prior to Randomisation.
14. Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 12 weeks from Randomisation or will require live vaccine(s) during the study period.
15. Have a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
16. Have any of the following abnormal laboratory test results at Screening or Day -1.

    1. Serum alanine transaminase (ALT) and/or aspartate transaminase (AST) ≥ 1.5 × upper limit of normal (ULN)
    2. Absolute neutrophil count \< 1,500 cells/μL
    3. Platelet count \< 100,000 cells/μL
    4. Any other laboratory abnormalities assessed as clinically significant by the Investigator
17. Have a positive test result for hepatitis B virus (HBV, defined as hepatitis B surface antigen \[HBsAg\] positive OR HBsAg negative and hepatitis B core antibody \[HBcAb\] positive), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.

    Note: HBV deoxyribonucleic acid (DNA) testing can be performed for participants with HBsAg negative and HBcAb positive results during the screening period. If HBV DNA testing is performed and the result is below the limit of detection (i.e., undetectable) during the screening period, participants with HBsAg negative and HBcAb positive results can be eligible.
18. Have a history of immunodeficiency.
19. Have a history and/or current present of an illness within 14 days prior to Randomisation that is classified as clinically significant by the Investigator.
20. Have major surgery in the opinion of the Investigator within 90 days prior to Randomisation, and/or plan to have an operation during the study period.
21. Current smoker or have smoked within 180 days prior to Randomisation.
22. Have regular consumption alcoholic beverages that exceeds 14 units per week (1 unit = 10 g of pure alcohol).
23. Have a positive urinary drug screening result or alcohol breath test result at Screening or Day -1.
24. Have taken any prescription medicine or over-the-counter medicines (except paracetamol) within 30 days prior to Randomisation that might have an effect on the objectives of the study in the opinion of the Investigator.
25. Have donated \> 100 mL whole blood within 8 weeks or component blood (including plasma) within 4 weeks prior to Randomisation.
26. Have participated in another study with an investigational drug within 180 days or 5 half-lives (whichever is longer) prior to the IP administration, or are currently participating in or intending to participate in another clinical study with an investigational drug before completion of all scheduled evaluations in this clinical study.
27. Participants with unsuitable injection site (e.g., tattoos, sunburn, or other skin disorders \[i.e., scars, lacerations, bruising, erythema, induration, tenderness, etc.\]) that may interfere with medical assessment of the injection site.
28. Participant who, in the opinion of the Investigator, is not likely to complete the study for whatever reason.
29. Participant who is the Investigator (including sub-Investigator), research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the clinical study.
30. Vulnerable participants (e.g., persons kept in detention).