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Clinical Trials in Australia / NCT07712939
Recruiting Phase 1

A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases

NCT07712939 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2026-07-20
Last updated
2026-07-22

Condition(s) studied

Healthy Participants StudyRheumatoid ArthritisSjogren's Syndrome

Investigational drug(s) / intervention(s)

CND319

CND319: CND319

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria (SAD): 1. 18 to 65 years old 2. Body mass index 18-30 kg/m2 and weight 55-100 kg 3. Individuals in good health 4. Agree to abstain from consumption of alcohol 48 hours prior to study visits 5. Agree to the use of highly effective contraception as defined in the protocol Inclusion Criteria (MAD and Part 2 Expansion): Patients with RA: 1. 18 to 75 years old 2. Diagnosis of adult-onset RA 3. Class I-III RA 4. Moderately to severely active RA Patients with SjD: 1. 18 to 75 years old 2. Diagnosis of primary SjD Exclusion Criteria (SAD): 1. Inadequate clinical laboratory parameters at Screening 2. Active infection 3. Receipt of or inability to discontinue any excluded therapies 4. Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons 5. History of alcohol or drug abuse within last 12 months 6. Positive alcohol breathalyzer or drug screen prior to dosing 7. Inability to comply with protocol-mandated requirements 8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug 9. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study 10. Blood donation or significant blood loss within 30 days 11. Individuals considered to be part of a vulnerable population (eg, incarceration) 12. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial Exclusion Criteria for patients with RA or SjD: 1. Inadequate clinical laboratory parameters at Screening 2. Active infection 3. Receipt of or inability to discontinue any excluded therapies 4. History of progressive multifocal leukoencephalopathy 5. Central nervous system disease 6. Presence of 1 or more significant concurrent medical conditions 7. Have a diagnosis or history of malignant disease within 5 years 8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug 9. Women who are pregnant or breastfeeding 10. Patients who do not agree to the use of highly effective contraception as defined by the protocol

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Candid Clinical Site Melbourne Victoria Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07712939 on ClinicalTrials.gov ↗ ← All trials in Australia