Actively Recruiting
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participants
Led by DualityBio Inc. · Updated on 2025-12-18
148
Participants Needed
4
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
CONDITIONS
Official Title
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who understand the study and voluntarily agree by signing consent
- Healthy males or females aged 18 to 55 years for Part A
- No clinically significant abnormalities based on medical history, exam, labs, and ECG for Part A
- Females of childbearing potential or males agree to use effective contraception
- Willing and able to comply with study treatments and evaluations
- Males or females aged 18 to 70 years for Part B
- Stable SLE or CLE treatment for at least 1 month prior to randomization
- Meet classification criteria for SLE or have histologically confirmed CLE
- Positive antinuclear antibodies or anti-double-stranded DNA antibodies for SLE
- Active lupus skin disease at screening for SLE
- Active CLE despite conventional therapies for CLE
You will not qualify if you...
- History or evidence of clinically significant diseases for Part A
- History of herpes zoster or recurrent herpes simplex infections
- Active or suspected bacterial, viral, fungal, or parasitic infection within 30 days before dosing
- Sensitivity to any ingredients of DB-2304
- Surgery within the past 3 months or planned during the study
- Active lupus nephritis or moderate-to-severe or chronic kidney disease for Part B
- Active neuropsychiatric SLE within 8 weeks before screening
- Active skin conditions or arthritis other than SLE that could affect assessments
- History or ongoing malignant disease except certain skin and cervical cancers excised over 2 years ago
- Known primary immunodeficiency, splenectomy, or conditions increasing infection risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
US03-0
Clearwater, Florida, United States, 33765
Actively Recruiting
2
US04-0
Irving, Texas, United States, 75061
Actively Recruiting
3
US02-0
San Antonio, Texas, United States, 78215
Actively Recruiting
4
Site AUS01-0
Melbourne, Victoria, Australia, 3004
Completed
Research Team
S
Sally Li
CONTACT
C
Cong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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