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.
This is a Phase 1, first-in-human, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy participants and patients with rheumatic diseases. The study consists of two parts: a dose escalation part and an open-label expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
CND319
Candid Clinical Site
Melbourne, Victoria, Australia
RECRUITINGIncidence proportion and severity of treatment-emergent adverse events through end of study
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to body temperature
oral, tympanic, or axillary
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to heart rate
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to respiratory rate
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to blood pressure
systolic and diastolic
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to pulse oximetry
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: PR interval
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: QRS interval
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: QT interval
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in safety laboratory assessments through end of study
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
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PK parameters for CND319: Maximum observed concentration (Cmax)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Time to maximum observed concentration (Tmax)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Area under the concentration-time curve (AUC)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Apparent clearance (CL/F)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Apparent volume of distribution (Vz/F)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Terminal elimination half-life (t1/2)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Frequency of participants/patients with anti-drug antibodies (ADAs)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Percentage of participants/patients with anti-drug antibodies (ADAs)
Time frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)