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HealthyPhase 1NCT07789964

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

A Phase 1 study testing Ixekizumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 3 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Ixekizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
3 sitesSouth Korea
Study dates
4 Sep 2026to 9 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or female, aged 19-55 years (inclusive) on the day of signing the informed consent form (ICF).
  • 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.
  • Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
  • Have vital sign results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
  • Have physical examination results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
  • 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.
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  • Female participants of non-childbearing potential, defined as one of the following:
  • 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.
  • 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.
  • Willing and able to comply with the scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifecycle considerations.
  • Provision of signed and dated written informed consent, which must be obtained prior to any study-related procedures being performed.

Who cannot join

  • 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.
  • 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.
  • 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.
  • Have a history of significant respiratory disorder (including asthma and non-infectious pneumonia).
  • Have a history of malignancy (including lymphoma, leukaemia, and skin cancer).
  • 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.
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  • Have a history of serious infection (associated with hospitalisation and/or which required intravenous [IV] antibiotics) within 8 weeks prior to Randomisation.
  • 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.
  • Have a clinically significant active infection (bacterial, viral, or fungal) within 28 days prior to Randomisation.
  • Have or have had a herpes zoster infection within 12 weeks prior to Randomisation.
  • Have previously been exposed to ixekizumab (Taltz and/or its biosimilar).
  • 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.
  • 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.
  • 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.
  • Have a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
  • Have any of the following abnormal laboratory test results at Screening or Day -1.
  • Serum alanine transaminase (ALT) and/or aspartate transaminase (AST) ≥ 1.5 × upper limit of normal (ULN)
  • Absolute neutrophil count < 1,500 cells/μL
  • Platelet count < 100,000 cells/μL
  • Any other laboratory abnormalities assessed as clinically significant by the Investigator
  • 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.
  • Have a history of immunodeficiency.
  • 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.
  • 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.
  • Current smoker or have smoked within 180 days prior to Randomisation.
  • Have regular consumption alcoholic beverages that exceeds 14 units per week (1 unit = 10 g of pure alcohol).
  • Have a positive urinary drug screening result or alcohol breath test result at Screening or Day -1.
  • 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.
  • Have donated > 100 mL whole blood within 8 weeks or component blood (including plasma) within 4 weeks prior to Randomisation.
  • 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.
  • 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.
  • Participant who, in the opinion of the Investigator, is not likely to complete the study for whatever reason.
  • 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.
  • Vulnerable participants (e.g., persons kept in detention).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Samsung Bioepis contact

+82-32-728-0114

bioepisinfo@samsung.com

South Korea3 sites, 3 recruiting

  • Research Site

    Busan, Busan

    Recruiting

  • Research Site

    Cheongju-si, North Chungcheong

    Recruiting

  • Research Site

    Seoul, Seoul

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase I, 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

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.

Conditions
Healthy
Being tested
Ixekizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxekizumabDrug

    80 mg, single-dose

Study groups in NCT07789964
Study groupRoleWhat they receive
SB35ExperimentalSB35 (proposed ixekizumab biosimilar)
Receives: Drug: Ixekizumab
TaltzActive comparatorTaltz (ixekizumab)
Receives: Drug: Ixekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCinf

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

    Measured: Day 1 to Day 85

  2. Cmax

    Maximum serum concentration

    Measured: Day 1 to Day 85

  3. AUClast

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

    Measured: Day 1 to Day 85

Secondary outcomes (11)

  1. Tmax

    Time to reach Cmax

    Measured: Day 1 to Day 85

  2. Vz/F

    Apparent volume of distribution during the terminal phase

    Measured: Day 1 to Day 85

  3. λz

    Terminal rate constant

    Measured: Day 1 to Day 85

  4. t1/2

    Terminal half-life

    Measured: Day 1 to Day 85

  5. CL/F

    Apparent clearance

    Measured: Day 1 to Day 85

  6. %AUCextrap

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

    Measured: Day 1 to Day 85

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

    Measured: Day 1 to Day 169

  8. Incidence of serious adverse events (SAEs)

    Measured: Day 1 to Day 169

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

    Measured: Day 1 to Day 169

  10. Titre of ADAs to ixekizumab

    Measured: Day 1 to Day 169

  11. Incidence of neutralising antibodies (NAbs) to ixekizumab

    Measured: Day 1 to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start4 Sep 2026
  3. Primary completion9 Jun 2027 (estimated)
  4. Study completion9 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789964
Sponsor's protocol ID
SB35-1001
Status last verified
Oct 2026
First submitted
20 Aug 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixekizumab in people with Healthy, run by Samsung Bioepis Co., Ltd. at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Samsung Bioepis (+82-32-728-0114, bioepisinfo@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCinf (time frame: Day 1 to Day 85). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07789964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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Clinical Trial NCT07789964 | AzTrials