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

NCT07712939 | Recruiting Phase 1

• 1 other identifier: CND319-101
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants Study; Rheumatoid Arthritis; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• 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)

Study Arms (1)

CND319

EXPERIMENTAL

CND319 will be dosed according to the assigned cohort

Biological: CND319

Interventions

CND319 BIOLOGICAL

CND319

CND319

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients with RA:
• to 75 years old
• Diagnosis of adult-onset RA
• Class I-III RA
• Moderately to severely active RA
• Patients with SjD:
• to 75 years old
• Diagnosis of primary SjD

You may not qualify if:

• 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
• Inadequate clinical laboratory parameters at Screening
• Active infection
• Receipt of or inability to discontinue any excluded therapies

Sponsors & Collaborators

• Candid Therapeutics: lead

Study Sites (1)

Candid Clinical Site

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Clinical Operations

CONTACT

8582470550; ClinicalTrials@candidrx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)