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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 18 to 75 years old
• Diagnosis of adult-onset RA for at least 6 months
• Moderately to severely active RA
• Inadequate treatment response as defined in the protocol
• RF + or ACPA+
• Stable use of traditional DMARDs is permitted
• Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Locations
Other Locations
Australia
Kali Therapeutics Trial Site
RECRUITING
Bayswater
New Zealand
Kali Therapeutics Trial Site
RECRUITING
Auckland
Contact Information
Primary
Trial Information
clinical@kalitherapeutics.com
1-858-888-3080
Time Frame
Start Date: 2026-07-13
Estimated Completion Date: 2028-07
Participants
Target number of participants: 27
Treatments
Experimental: Part A (SAD): Non-Fractionated Single Ascending Doses / Dose Finding
Participants will receive a KT502 Subcutaneous Injection at an assigned dose as on Day 1
Experimental: Part B: Fractionated Dosing / Dose Escalation
Participants will receive a KT502 Subcutaneous Injection as a step-up/fractionated dosing on Day 1 and Day 8
Related Therapeutic Areas
Sponsors
Leads: Kali Therapeutics, Inc.