A First-in-human Study of KT501 Administered Subcutaneously to Patients With Rheumatoid Arthritis (RA).
Recruiting
Phase 1
Interventional Study
Rheumatoid Arthritis (RA)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Kali Therapeutics, Inc. · Industry
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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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 18 to 75 years old
2. Diagnosis of adult-onset RA for at least 6 months
3. Moderately to severely active RA
4. Inadequate treatment response as defined in the protocol
5. RF + or ACPA+
6. Stable use of traditional DMARDs is permitted
7. Willing and able to comply with all stu…
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