A Phase 1a, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT501 by a Single Subcutaneous Administration in Participants With Rheumatoid Arthritis

Official Summary

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: SEQUENTIAL
• Masking: NONE
• Enrollment: 24 participants

Interventions

• DRUG: KT501 — KT501 is a monoclonal antibody that depletes B cells including plasma cells by targeting CD19, BCMA and CD3.

Primary Outcomes

• Incidence of Adverse Events (From Baseline Up to 12 weeks)
• Incidence of Cytokine-release Syndrome (CRS) (From Baseline Up to 12 Weeks)
• Changes in Pulse Rate from Baseline (From Baseline Up to 12 Weeks)
• Changes in Respiratory Rate from Baseline (From Baseline to 12 Weeks)
• Changes in Blood Pressure from Baseline (From Baseline Up to Week 12)

Secondary Outcomes

• Serum Concentrations of KT501 (Pre-dose and 6 hours post-dose on Day 1; Day 2, 3, 4, 5, 8, 11, 15, 22, 29, 43, 57 and 85.)
• Incidence of Treatment-induced Anti-Drug Antibodies (ADAs) (Pre-dose and on Day 1; Day 8, 11, 15, 22, 29, 43, 57 and 85.)
• To Determine Cmax (Day 1 - Day 85)
• To Determine Tmax, Derived from Serum Concentration of each Dose of KT501 (Day 1 - Day 85)
• Area Under the Serum-concentration Time Curve (AUC) from Time Zero to the Last Timepoint with Measurable Analyte Concentration (AUC0-t) (Day 1 - Day 85)

Trial Locations

• Kali Study Site, Bayswater, Australia

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