ClinicalTrials.gg
RecruitingNCT07789964Updated Oct 14, 2026

A Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of SB35 (Proposed Ixekizumab Biosimilar) to Taltz in Healthy Participants

A Phase 1 interventional study of Ixekizumab in Healthy, sponsored by Samsung Bioepis Co., Ltd.. Recruiting at 3 sites in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Samsung Bioepis Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Oct 14, 2026Now RecruitingFirst site in South Korea+2 moreGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

This is a randomised, double-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of ixekizumab (SB35 and Taltz) in healthy participants.

Read the detailed description

This is a randomised, double-blind, two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of ixekizumab (SB35 and Taltz) in healthy participants. Participants will be randomised 1:1 to receive a single dose of either SB35 or Taltz. All investigational products (IPs) will be administered subcutaneously in the abdomen.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy male or female, aged 19-55 years (inclusive) on the day of signing the form (ICF).
  2. Have a body weight between 55.0-90.0 kg (inclusive) and a (BMI) between 20.0-29.9 kg/m2 (inclusive) at Screening and Day -1.
  3. Have 12-lead (ECG) results without 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-, defined as one of the following:

    1. (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 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

Exclusion Criteria:

  1. Have a history and/or current presence of atopic allergy, , 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 .
  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 (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 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 (s) during the study period.
  15. Have a personal or family history of prolonged 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 (ALT) and/or aspartate transaminase (AST) ≥ 1.5 × (ULN)
    2. \< 1,500 cells/μL
    3. count \< 100,000 cells/μL
    4. Any other laboratory abnormalities assessed as clinically significant by the Investigator
  17. Have a positive test result for virus (HBV, defined as hepatitis B surface antigen [HBsAg] positive OR HBsAg negative and hepatitis B core antibody [HBcAb] positive), virus (HCV) antibody, or (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 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).
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
174 participants (estimated)

Study arms

  • Experimental
    SB35

    SB35 (proposed ixekizumab biosimilar)

    Drug: Ixekizumab

  • Active comparator
    Taltz

    Taltz (ixekizumab)

    Drug: Ixekizumab

Interventions

06

What researchers measure

Primary outcomes

  1. AUCinf

    Area under the concentration-time curve from time zero to infinity

    Time frame: Day 1 to Day 85

  2. Cmax

    Maximum serum concentration

    Time frame: Day 1 to Day 85

  3. AUClast

    Area under the concentration-time curve from time zero to the last quantifiable concentration

    Time frame: Day 1 to Day 85

Secondary outcomes

  1. Tmax

    Time to reach Cmax

    Time frame: Day 1 to Day 85

  2. Vz/F

    Apparent volume of distribution during the terminal phase

    Time frame: Day 1 to Day 85

  3. λz

    Terminal rate constant

    Time frame: Day 1 to Day 85

  4. t1/2

    Terminal half-life

    Time frame: Day 1 to Day 85

  5. CL/F

    Apparent clearance

    Time frame: Day 1 to Day 85

  6. %AUCextrap

    Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity

    Time frame: Day 1 to Day 85

  7. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Day 1 to Day 169

  8. Incidence of serious adverse events (SAEs)

    Time frame: Day 1 to Day 169

  9. Incidence of anti-drug antibodies (ADAs) to ixekizumab

    Time frame: Day 1 to Day 169

  10. Titre of ADAs to ixekizumab

    Time frame: Day 1 to Day 169

  11. Incidence of neutralising antibodies (NAbs) to ixekizumab

    Time frame: Day 1 to Day 169

07

Study locations

3 of 3 sites recruiting
  • Research Site
    Busan, Busan, South Korea
    Recruiting
  • Research Site
    Cheongju-si, North Chungcheong, South Korea
    Recruiting
  • Research Site
    Seoul, Seoul, South Korea
    Recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Jun 2027, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 27, 2026
StartActual
Sep 4, 2026
Primary completionEst.
Jun 9, 2027
CompletionEst.
Jun 9, 2027
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 14, 2026
Sites
3 sites added — first site in South Korea
Show 3 added (3 South Korea)
  • Research Site · Busan, South Korea
  • Research Site · Cheongju-si, South Korea
  • Research Site · Seoul, South Korea
Oct 14, 2026
Start date
Sep 2, 2026→Sep 4, 2026 (actual)
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Not yet recruiting→Recruiting
    3 sites added — first site in South Korea
    Show 3 added (3 South Korea)
    • Research Site · Busan, South Korea
    • Research Site · Cheongju-si, South Korea
    • Research Site · Seoul, South Korea
    Start date Sep 2, 2026→Sep 4, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07789964
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Sep 4, 2026
Primary completion
Jun 9, 2027 (estimated)
Completion
Jun 9, 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Samsung Bioepis
Contact
bioepisinfo@samsung.com
+82-32-728-0114

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ixekizumab

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