What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are CND319. The registry lists allocation as na. This study wants to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.
They plan to enroll about 105 people at Melbourne. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
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
Interventions: CND319
Primary outcome (registry wording): Incidence proportion and severity of treatment-emergent adverse events through end of study