Phase 1/2a Study of DB-2304 for Lupus
This study is testing a new drug called DB-2304 in healthy adults and people with Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus (CLE). We want to see how safe DB-2304 is and if it causes any side effects. Some participants will receive DB-2304, others will receive a placebo (an inactive substance), and some may receive Prednisone, a common lupus medication. We will be looking at side effects (TEAEs and SAEs) and heart activity (ECG parameters) for up to 280 days. The study is open to adults aged 18 to 70. The study aims to enroll 148 participants, but its current status is unclear.
- Study design
- This is an interventional Phase 1/2a study, meaning participants will receive specific treatments. It plans to enroll 148 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for up to 112 days in Part A and up to 280 days in Part B after their last study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
At a glance
Conditions
Where it's being run
7 sites across 5 statesStudy leadership
- Lily Hu · STUDY_DIRECTOR · DualityBio Inc.
Who to contact
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What this trial measures
- TEAEsUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
Treatment-emergent adverse events
- SAEsUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
serious adverse events
- ECG parametersUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
12-lead electrocardiograms parameters including HR, PR, QT intervals, QTcF intervals for Fredericia's formula-QT corrected interval), and QRS duration should be determined.
- Weight measurementsUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
Change and Rate of Change from Baseline in weight
- Heart Rate measurementsUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
Change and Rate of Change from Baseline in heart rate
- Pulse rate measurementsUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
Change and Rate of Change from Baseline in pulse rate
- Respiratory rate measurementsUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
Change and Rate of Change from Baseline in respiratory rate
- Body temperature measurementsUp to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
Change and Rate of Change from Baseline in body temperature