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
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:
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- 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
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- 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