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

Official title

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

Overview

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

• Biological CND319
  CND319

Primary outcome measures

• Incidence 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 [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 [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)]

Secondary outcome measures (8)

• 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Australia · 1 center

• Candid Clinical Site — Melbourne

Identifiers

NCT: NCT07712939 · CND319-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗