Phase 1 Study With KIN-1901 in Healthy Subjects & Subjects With Ankylosing

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04205851
Study type	Interventional
Source	Kinevant Sciences GmbH
Contact
Status	Completed
Phase	Phase 1
Start date	November 12, 2019
Completion date	April 7, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms