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

July 21, 2026 updated by: Candid Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CND319
CND319 will be dosed according to the assigned cohort
Biological: CND319
CND319

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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)
oral, tympanic, or axillary
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)
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)
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)
systolic and diastolic
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)
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)
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)
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)
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)
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK parameters for CND319: Maximum observed concentration (Cmax)
Time Frame: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
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)
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)
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)
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)
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)
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)
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)
Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Candid Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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