Healthy Participants Study, Rheumatoid Arthritis, Sjogren's Syndrome
Conditions
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALCND319
CND319
Sponsors
Candid Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This open-label, Phase 1, FIH, single ascending dose (SAD) and multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of CND319 in healthy participants (Part 1: SAD) and patients with RA or SjD (Part 1: MAD and Part 2 Expansion). The study consists of 2 parts: dose-escalation (Part 1: SAD and MAD) and expansion (Part 2).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters for CND319: Maximum observed concentration (Cmax) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
| PK parameters for CND319: Time to maximum observed concentration (Tmax) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
| PK parameters for CND319: Area under the concentration-time curve (AUC) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
| PK parameters for CND319: Apparent clearance (CL/F) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
| PK parameters for CND319: Apparent volume of distribution (Vz/F) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
| PK parameters for CND319: Terminal elimination half-life (t1/2) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
| Frequency of participants/patients with anti-drug antibodies (ADAs) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
| Percentage of participants/patients with anti-drug antibodies (ADAs) | Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2) |
Countries
Australia
Contacts
CONTACTClinical Operations
Outcome results
None listed