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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis; Sjogren's Syndrome; Healthy Participants Study
• Intervention / Treatment: Biological: CND319

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Operations; Phone Number: 8582470550; Email: ClinicalTrials@candidrx.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Candid Clinical Site
      • Contact: Clinical Operations; Phone Number: 8582470550; Email: ClinicalTrials@candidrx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria for patients with RA or SjD:

1. Inadequate clinical laboratory parameters at Screening
2. Active infection
3. Receipt of or inability to discontinue any excluded therapies
4. History of progressive multifocal leukoencephalopathy
5. Central nervous system disease
6. Presence of 1 or more significant concurrent medical conditions
7. Have a diagnosis or history of malignant disease within 5 years
8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug
9. Women who are pregnant or breastfeeding
10. Patients who do not agree to the use of highly effective contraception as defined by the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CND319; CND319 will be dosed according to the assigned cohort	Biological: CND319; CND319

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	oral, tympanic, or axillary	Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
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	systolic and diastolic	Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Candid Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Arthritis, Rheumatoid
• Other Study ID Numbers: CND319-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No