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

NCT07789964 | Not Yet Recruiting Phase 1

• 1 other identifier: SB35-1001
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• AUCinf

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

  Day 1 to Day 85

• Cmax

  Maximum serum concentration

  Day 1 to Day 85

• AUClast

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

  Day 1 to Day 85

Secondary Outcomes (11)

• Tmax

  Day 1 to Day 85

• Vz/F

  Day 1 to Day 85

• λz

  Day 1 to Day 85

• t1/2

  Day 1 to Day 85

• CL/F

  Day 1 to Day 85

Study Arms (2)

SB35

EXPERIMENTAL

SB35 (proposed ixekizumab biosimilar)

Drug: Ixekizumab

Taltz

ACTIVE COMPARATOR

Taltz (ixekizumab)

Drug: Ixekizumab

Interventions

Ixekizumab DRUG

80 mg, single-dose

SB35; Taltz

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

MeSH Terms

Interventions

ixekizumab

Central Study Contacts

Samsung Bioepis

CONTACT

+82-32-728-0114; bioepisinfo@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 2, 2026
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): June 9, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08