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

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT07789964
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 2, 2026
Status verified
Aug 2026
Primary completion
Jun 9, 2027
Completion
Jun 9, 2027

Study Design

Enrollment
174 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: SB35
    SB35 (proposed ixekizumab biosimilar)
  • Active Comparator: Taltz
    Taltz (ixekizumab)

Primary Outcome Measure

AUCinf [ Time Frame: Day 1 to Day 85 ]

Central Contacts

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