Healthy Participants StudyPhase 1NCT07712939
A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases
A Phase 1 study testing CND319 in people with Healthy Participants Study and Rheumatoid Arthritis, run by Candid Therapeutics at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study, Rheumatoid Arthritis, Sjogren's Syndrome
- What is being tested?
- CND319
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Jul 2026to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Patients with RA:
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Candid Clinical Site
Melbourne, Victoria
Clinical Operations, 8582470550, ClinicalTrials@candidrx.com
About this study
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
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.
Read the 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.
- Being tested
- CND319
- Medical subject headings
- Arthritis, Rheumatoid, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CND319Biological
CND319
| Study group | Role | What they receive |
|---|---|---|
| CND319 | Experimental | CND319 will be dosed according to the assigned cohort Receives: Biological: CND319 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence proportion and severity of treatment-emergent adverse events through end of study
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to body temperature
oral, tympanic, or axillary
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to heart rate
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to respiratory rate
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to blood pressure
systolic and diastolic
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to pulse oximetry
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: PR interval
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: QRS interval
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: QT interval
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in safety laboratory assessments through end of study
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Secondary outcomes (8)
PK parameters for CND319: Maximum observed concentration (Cmax)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Time to maximum observed concentration (Tmax)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Area under the concentration-time curve (AUC)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Apparent clearance (CL/F)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Apparent volume of distribution (Vz/F)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
PK parameters for CND319: Terminal elimination half-life (t1/2)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Frequency of participants/patients with anti-drug antibodies (ADAs)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Percentage of participants/patients with anti-drug antibodies (ADAs)
Measured: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start22 Jul 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712939
- Sponsor's protocol ID
- CND319-101
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07712939
- Acronym / sponsor ID
- CND319-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Candid TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| CND319 | Experimental | Biological: CND319CND319 will be dosed according to the assigned cohort |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CND319CND319 | Biological | CND319 |
Primary outcome
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)
oral, tympanic, or axillary
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)
systolic and diastolic
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)
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants Study
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruitingObservational study
Screening Protocol
Pain
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CND319 in people with Healthy Participants Study and Rheumatoid Arthritis, run by Candid Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations (8582470550, ClinicalTrials@candidrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.