Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis
This study is intended to treat ankylosing spondylitis (AS). AS is a form of arthritis that primarily affects the spine. It is characterized by inflammation of the spinal joints that can lead to severe pain, and in more advanced cases, ankylosis (sections of the spine fuse in a fixed, immobile position). The study will be an ascending single and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous KIN-1901 in healthy subjects and subjects with AS.
Condition or disease Intervention/treatment Phase
KIN-1901 is a fully human immunoglobulin monoclonal antibody (mAb) directed towards a proinflammatory cytokine that is believed to have a role in inflammation and autoimmunity, and is found in synovial fluid from patients with spondyloarthritis. Therefore, neutralization of this cytokine activity by specific monoclonal antibodies (mAbs) could be beneficial in treating certain spondyloarthropathies such as ankylosing spondylitis (AS).
The primary objective of the study is to evaluate the safety and tolerability of escalating single-dose or once-weekly repeat-dose subcutaneous (SC) administration of KIN-1901 in healthy subjects (Cohorts 1 through 4) and in subjects with AS (Cohort 5). The secondary objective of the study is to evaluate the pharmacokinetics (PK) of escalating single-dose and once-weekly repeat-dose SC administration of KIN-1901 in healthy subjects (Cohorts 1 through 4) and in subjects with AS (Cohort 5). The following exploratory objectives will also be evaluated: (1) To explore the pharmacodynamic (PD) effects of escalating single-dose and once-weekly repeat-dose SC administration of KIN-1901 in healthy subjects (Cohorts 1 through 4), (2) To explore the PD effects and changes in disease activity by Assessment in Ankylosing Spondylitis Criteria ASAS 20/40 (and components) and Ankylosing Spondylitis Disease Activity Score-CRP (ASDAS-CRP) of once-weekly repeat-dose SC administration of KIN-1901 in subjects with AS (Cohort 5), (3) To assess biomarkers of efficacy and safety after once-weekly repeat-dose SC administration of KIN-1901 in subjects with AS (Cohort 5).
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Study Type : Interventional
Actual Enrollment : 36 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Randomized, double-blind (Sponsor unblind), multi-cohort, placebo-controlled design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Gimsilumab in Healthy Subjects and Subjects With Ankylosing Spondylitis
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020