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)
Incidence proportion and severity of treatment-emergent adverse events through end of study — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to body temperature — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) oral, tympanic, or axillary
Changes to heart rate — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to respiratory rate — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to blood pressure — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) systolic and diastolic
Changes to pulse oximetry — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: PR interval — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: QRS interval — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: QT interval — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in safety laboratory assessments through end of study — Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
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.
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