Actively Recruiting
A First-in-Human, Phase 1, Open-Label Study to Evaluate Safety and Tolerability of Intravenous CPTX2309 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis or Systemic Lupus Erythematosus
Led by Capstan Therapeutics · Updated on 2026-04-01
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of CPTX2309 in healthy adults and adults with moderate to severe rheumatoid arthritis or systemic lupus erythematosus. This first-in-human Phase 1 study involves intravenous administration of CPTX2309 and aims to understand its effects in these populations. The study includes participants with confirmed diagnoses based on established classification criteria for RA and SLE. The study has multiple parts involving escalating single and multiple intravenous doses of CPTX2309. Healthy volunteers and participants with RA or SLE receive increasing doses on specified days to assess safety and tolerability. The design includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts for both healthy individuals and those with the autoimmune conditions. Participants will attend scheduled visits for medical evaluations, laboratory tests, vital signs monitoring, ECGs, and assessments of immune response markers for up to about one year. Researchers will monitor changes in safety parameters, antibody titers, pharmacokinetics, and pharmacodynamics. Safety follow-up includes tracking anti-drug antibodies and immune complex formation. This extended monitoring helps evaluate the body's response and any potential side effects related to CPTX2309.
CONDITIONS
Brief Title
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 to 65 who are healthy or have moderate to severe rheumatoid arthritis or systemic lupus erythematosus
- Willing and able to follow the study visit schedule and protocol requirements
- For rheumatoid arthritis participants: clinical diagnosis of RA meeting 2010 ACR/EULAR criteria
- Presence of rheumatoid factor or ACPA above the upper limit of normal for RA participants
- Moderate active RA disease with at least 6 swollen and 6 tender joints or at least 3 joints with active synovitis by MRI
- For systemic lupus erythematosus participants: clinical diagnosis of SLE meeting 2019 EULAR/ACR criteria
- Positive ANA ≥1:80 and presence of anti-double stranded DNA or anti-Smith antibodies above upper limit of normal for SLE participants
You will not qualify if you...
- Evidence of organ dysfunction or significant abnormalities in physical exam, vital signs, or lab tests inconsistent with a healthy population
- Use of investigational medical devices or drugs within 30 days or 5 half-lives before CPTX2309 administration
- For rheumatoid arthritis participants: diagnosis of Felty's syndrome
- For systemic lupus erythematosus participants: active neuropsychiatric SLE within 6 months before screening (except lupus headache)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Single dose or multiple doses over specified days depending on cohort assignment
Participants receive escalating single or multiple intravenous doses of CPTX2309 to evaluate safety and tolerability.
1 to multiple infusion visits depending on cohort assignment
Duration - Up to approximately 1 year
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and immunogenicity up to approximately 1 year after dosing.
Periodic visits for safety and laboratory assessments during follow-up
Trial Site Locations
Total: 1 location
1
Nucleus Network Brisbane
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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