Healthy Participants Study study: CND319
Official title A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases
ClinicalTrials.gov ID: NCT07712939
What this study is testing
What is CND319?
CND319 is an investigational biological medicine being studied for use in healthy adults and patients with rheumatic diseases.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and well tolerated CND319 is, how it moves through the body, how it affects the body, whether it triggers immune reactions, and if it shows any early signs of helping the disease.
- Who it's for
- Healthy adults and patients with rheumatoid arthritis or Sjögren’s syndrome.
- What's involved
- Participants will receive CND319 and attend scheduled visits for medical checks and blood tests to monitor safety and drug levels.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
- 18 to 75 years old
You likely can't join 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
See the full eligibility criteria
- 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
- 18 to 75 years old
- Diagnosis of adult-onset RA
- Class I-III RA
- 18 to 75 years old
- Diagnosis of primary SjD
- 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)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Melbourne, Victoria, Australia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.