Tests CPTX2309 safety in healthy adults and in people with rheumatoid arthritis or lupus
Tests CPTX2309 safety in healthy adults and adults with rheumatoid arthritis or lupus.
Plain-language title generated from the registry record
Registry title: A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
Key facts
- Where
- Bayswater, Herston, and Nedlands, AustraliaSee the 3 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults and adults with moderate to severe rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE) to test the safety of CPTX2309.
- Age
- 18 Years to 65 Years
- Sex
- All sexes can join.
- Disease stage
- RA: at least moderate active disease, with at least 6 swollen and 6 tender joints, or at least 3 joints with active synovitis on MRI. SLE: a clinical diagnosis of SLE meeting the 2019 EULAR/ACR criteria. Healthy volunteers can also join.
- Earlier treatment
- Cannot have used any investigational drug or device within 30 days or 5 half-lives of the drug (whichever is longer) before the first dose of CPTX2309.
- Biomarker or test result
- RA: rheumatoid factor or ACPA above the upper limit of normal. SLE: ANA of 1:80 or higher and anti-dsDNA or anti-Sm above the upper limit of normal.
Main reasons for not taking part
- Organ dysfunction or clinically significant abnormal exam, vital signs or lab tests, beyond what is normal for a healthy population
- Use of an investigational drug or device within 30 days or 5 half-lives before the first dose
- RA: Felty's syndrome
- SLE: active neuropsychiatric lupus, or signs of it within 6 months before screening
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06917742, who can take part
Where in Australia
- Veritus ResearchBayswater, AustraliaTaking people
- Nucleus Network BrisbaneHerston, AustraliaNo longer taking part
- Linear Clinical ResearchNedlands, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Capstan Therapeutics
- Trial code
- NCT06917742
- Record updated
- 16 July 2026
- Original description
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.Read full original descriptionShow less
A First-in-Human, Phase 1, Open-Label, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CPTX2309 by Intravenous Administration in Healthy Volunteers and Subjects With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
Inclusion: Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examination, and clinical laboratory tests obtained during the screening period; Participant is willing and able to adhere to the study visit schedule and other protocol requirements; RA Only:; Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA; Presence of rheumatoid factor or ACPA above the ULN; Confirmation of at least moderate active disease at screening with the presence of at least 6 swollen and 6 tender joints at screening using the 68 (tender)/66 (swollen) joint count OR the presence of at least 3 joints with active synovitis via MRI assessment; SLE Only:; Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria for SLE; Positive ANA>=1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double standard DNA (dsDNA) or anti-Smith (Sm).
Exclusion: Use of any investigational medical device or investigational drug within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the first administration of CPTX2309; RA Only:; Active neuropsychiatric SLE, as defined by the CNS portion of SLEDAI at Screening, or signs of symptoms of neuropsychiatric SLE within 6 months prior to Screening (lupus headache permissible); Participants diagnosed with Felty's syndrome; SLE Only:; Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted; Note: Other protocol-defined inclusion/exclusion criteria apply.