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NOT YET RECRUITING
NCT07789964
PHASE1

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.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

174

Start Date

2026-09-02

Completion Date

2027-06-09

Last Updated

2026-08-27

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Ixekizumab

80 mg, single-dose