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

ConditionRheumatoid Arthritis (RA)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorKali Therapeutics, Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

KT502

Treatment groups

27 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Kali Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov