A Randomized, Double-Blind, Phase 1/2a Study to Evaluate the Safety, Tolerability, PK and PD of DB-2304 for Injection in Healthy Adult Participants and Participants With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Not specified
- Sponsor
- DualityBio Inc.
- Enrollment
- 148
- Locations
- 4
- Primary Endpoint
- TEAEs
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose Level 7
Intervention: Placebo
Dose Level 8
Intervention: DB-2304
Dose Level 8
Intervention: Placebo
Dose Level 1
Intervention: DB-2304
Dose Level 1
Intervention: Placebo
Dose Level 1
Intervention: Prednisone
Dose Level 2
Intervention: DB-2304
Dose Level 2
Intervention: Placebo
Dose Level 2
Intervention: Prednisone
Dose Level 3
Intervention: DB-2304
Dose Level 3
Intervention: Placebo
Dose Level 3
Intervention: Prednisone
Dose Level 4
Intervention: DB-2304
Dose Level 4
Intervention: Placebo
Dose Level 4
Intervention: Prednisone
Dose Level 5
Intervention: DB-2304
Dose Level 5
Intervention: Placebo
Dose Level 5
Intervention: Prednisone
Dose Level 6
Intervention: DB-2304
Dose Level 6
Intervention: Placebo
Dose Level 7
Intervention: DB-2304
Outcomes
Primary Outcomes
TEAEs
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B
Treatment-emergent adverse events
SAEs
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B
serious adverse events
ECG parameters
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last 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 measurements
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B
Change and Rate of Change from Baseline in weight
Heart Rate measurements
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B
Change and Rate of Change from Baseline in heart rate
Pulse rate measurements
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B
Change and Rate of Change from Baseline in pulse rate
Respiratory rate measurements
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B
Change and Rate of Change from Baseline in respiratory rate
Body temperature measurements
Time Frame: Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B
Change and Rate of Change from Baseline in body temperature