First test of CND319 in healthy adults and people with rheumatic diseases
Tests CND319 in healthy adults and people with rheumatoid arthritis or Sjogren's syndrome.
Plain-language title generated from the registry record
Registry title: A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases
Key facts
- Where
- Melbourne, AustraliaSee the site
- Phase
- Phase 1
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: NCT07712939, who can take part
Where in Australia
- MelbourneMelbourne, 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
- Candid Therapeutics
- Trial code
- NCT07712939
- Record updated
- 21 October 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.Read full original descriptionShow less
A Phase 1, First-In-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CND319 in Healthy Participants and Patients With Rheumatic Diseases
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.
Inclusion: 18 to 65 years old; Body mass index 18-30 kg/m2 and weight 55-100 kg; Individuals in good health; Agree to abstain from consumption of alcohol 48 hours prior to study visits; Agree to the use of highly effective contraception as defined in the protocol; Patients with RA:; 18 to 75 years old; Diagnosis of adult-onset RA; Class I-III RA; Moderately to severely active RA; Patients with SjD:; 18 to 75 years old; Diagnosis of primary SjD.
Exclusion: Receipt of or inability to discontinue any excluded therapies; Positive alcohol breathalyzer or drug screen prior to dosing; Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study; Receipt of or inability to discontinue any excluded therapies; Presence of 1 or more significant concurrent medical conditions; Active infection; History of alcohol or drug abuse within last 12 months; History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug; Active infection; History of progressive multifocal leukoencephalopathy; Central nervous system disease; Have a diagnosis or history of malignant disease within 5 years; History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug; Inadequate clinical laboratory parameters at Screening; Inadequate clinical laboratory parameters at Screening; Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons; Inability to comply with protocol-mandated requirements; Blood donation or significant blood loss within 30 days; Individuals considered to be part of a vulnerable population (eg, incarceration); Individuals that in the opinion of the Investigator, are not suitable for participation in the trial; Women who are pregnant or breastfeeding; Patients who do not agree to the use of highly effective contraception as defined by the protocol.