A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases

Sponsor
Candid Therapeutics
Study ID
NCT07712939
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • CND319 — BIOLOGICAL
    CND319

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
105 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CND319
    CND319 will be dosed according to the assigned cohort

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) ]

Central Contacts

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