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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing CND319 for Healthy Participants Study

This study wants to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.

Official registry: https://clinicaltrials.gov/study/NCT07712939 · Candid Therapeutics · enrollment listed as 105

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CND319. The registry lists allocation as na. This study wants to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.

They plan to enroll about 105 people at Melbourne. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: CND319

Primary outcome (registry wording): Incidence proportion and severity of treatment-emergent adverse events through end of study

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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
  • who can join (MAD and Part 2 Expansion):
  • Diagnosis of adult-onset RA
  • Moderately to severely active RA

Public study contact (from the registry)

Clinical Operations

8582470550

ClinicalTrials@candidrx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT07712939 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07712939?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07712939?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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