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

Inclusion criteria

• SAD):
• 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
• Inclusion Criteria (MAD and Part 2 Expansion):
• 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 criteria

• SAD):
• Inadequate clinical laboratory parameters at Screening
• Active infection
• Receipt of or inability to discontinue any excluded therapies
• Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons
• History of alcohol or drug abuse within last 12 months
• Positive alcohol breathalyzer or drug screen prior to dosing
• Inability to comply with protocol-mandated requirements
• History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug
• Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
• 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
• Exclusion Criteria for patients with RA or SjD:
• Inadequate clinical laboratory parameters at Screening
• Active infection
• Receipt of or inability to discontinue any excluded therapies
• History of progressive multifocal leukoencephalopathy
• Central nervous system disease
• Presence of 1 or more significant concurrent medical conditions
• 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
• Women who are pregnant or breastfeeding
• Patients who do not agree to the use of highly effective contraception as defined by the protocol