NCT07712939RecruitingPhase 1
A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases
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
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- Jul 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- Candid Therapeutics
- Diseases
- Sjögren's disease, Rheumatoid arthritis
- NCT number
- NCT07712939
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 105
- From Jul 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Inadequate clinical laboratory parameters at Screening
- Inadequate clinical laboratory parameters at Screening
Age
- Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.