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NOT YET RECRUITING
NCT07564154
PHASE1

A First-in-human Study of KT502 Administered Subcutaneously to Adult Participants With Rheumatoid Arthritis (RA)

Sponsor: Kali Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 1, open-label, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of KT502 administered subcutaneously to participants with Rheumatoid Arthritis (RA). The study will have 2 parts: Part A is a single ascending dose finding (SAD) and Part B is dose escalation by fractionated dosing.

Official title: A Phase 1, Open-Label, First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KT502 by Subcutaneous Administration in Adult Participants With Rheumatoid Arthritis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-07

Completion Date

2028-07

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DRUG

KT502

KT502 is a monoclonal antibody that depletes B cells by targeting CD19 and CD3

Locations (2)

Kali Therapeutics Trial Site

Bayswater, Victoria, Australia

Kali Therapeutics Trial Site

Auckland, NZ, New Zealand