A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid 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 KT501 administered subcutaneously to participants with Rheumatoid Arthritis (RA).

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

Functional class IV as defined by the ACR Classification of Functional Status in RA

Presence of any concomitant autoimmune disease other than RA

Active infection, history of serious recurrent or chronic infection

History of progressive multifocal leukoencephalopathy

Trial design

Treatments tested in this trial

  • KT501

Treatment groups

24 Participants
are divided into 5 treatment groups

Sponsors and collaborators