No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
105 (estimated)
Sponsor
Candid Therapeutics · Industry
Who this trial is looking for
This trial is looking for healthy adults and patients with rheumatoid arthritis or Sjogren's syndrome. Participants will help researchers learn more about the safety and effects of a new treatment called CND319.
Are You a Good Fit for This Trial?
Rules you outPregnancySevere allergic reactionsActive infectionCentral nervous system disease
You may be able to join if
I am between 18 and 75 years old.
I weigh between 55 and 100 kg.
I am in good health.
I have been diagnosed with rheumatoid arthritis or primary Sjogren's syndrome.
I agree to use effective contraception if I can become pregnant.
You may not be able to join if
I have an active infection.
I cannot stop taking certain medications required by the study.
I have a history of severe allergic reactions to specific therapies.
I am pregnant or breastfeeding.
I have a serious medical condition or recent major surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
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
Inclusio…
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
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