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
DualityBio Inc.
Summary
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria (Part A): 1. Participants who fully understand the purpose, nature, method, and potential adverse reactions of the study and voluntarily sign the informed consent form (ICF) and agree to participate. 2. Healthy male or female participants; 18 to 55 years of age (both inclusive) on the day of signing ICF; meet the body mass index (BMI) criteria. 3. Based on the investigator assessment, there are no abnormal findings or findings with clinical significance from the medical history consultation, physical examination, vital signs assessment, clinical laboratory tests, and 12-lea…
Interventions
- DrugDB-2304
DB-2304
- DrugPlacebo
Placebo
- DrugPrednisone
Prednisone
Locations (4)
- US03-0Clearwater, Florida
- US04-0Irving, Texas
- US02-0San Antonio, Texas
- Site AUS01-0Melbourne, Victoria