What is DB-2304 studying for Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus?

DB-2304 is being studied to evaluate its safety, tolerability, and how it works in the body for people with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus. The research aims to understand these effects in both healthy adults and those with these lupus conditions. DualityBio Inc. is leading this clinical trial to gather important information for future lupus treatments.

Who may be eligible for this lupus clinical trial?

Adults aged 18 to 70 years with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus may be eligible. Participants must be on a stable lupus treatment regimen for at least one month and willing to follow study procedures. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this lupus clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal expenses, such as travel costs, may vary and are not always covered. Participants should plan accordingly for these potential costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 70Years

All Genders

Healthy Volunteers

ID06625671

Phase 12a Study to Assess Safety and Effects of DB-2304 Injection in Healthy Adults and Adults with Systemic or Cutaneous Lupus Erythematosus

Led by DualityBio Inc. · Updated on 2026-06-02

148

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating DB-2304 in a Phase 12a study involving healthy adults and individuals with Systemic Lupus Erythematosus SLE or Cutaneous Lupus Erythematosus CLE. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of DB-2304 for injection in these participants. This trial is randomized and double-blind, sponsored by DualityBio Inc., and includes adults aged 18 to 70 years. Participants receive different dose levels of DB-2304 or placebo, with some also receiving prednisone as part of their stable treatment regimen. The study includes two parts Part A with healthy adults aged 18 to 55, and Part B with adults aged 18 to 70 having SLE or CLE. Treatments are administered by injection, and participants are randomly assigned to one of several dose levels to evaluate different dosing effects. During the study, participants will undergo monitoring for treatment-emergent adverse events, serious adverse events, and various vital signs including ECG, heart rate, respiratory rate, body temperature, and weight. These measurements are tracked for up to 112 days after treatment in Part A and up to 280 days after the first treatment in Part B. The study involves regular assessments to evaluate safety and treatment response over these periods.

CONDITIONS

Brief Title

A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants

Who Can Participate

Age: 18Years - 70Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Participants must understand the study and voluntarily sign informed consent.
Healthy males or females aged 18 to 55 years (Part A) or males or females aged 18 to 70 years (Part B).
Must meet body mass index criteria and have no clinically significant abnormal medical findings (Part A).
Females of childbearing potential and males must agree to use highly effective contraception during the study.
Participants with SLE/CLE must be on a stable treatment regimen for at least 1 month prior to randomization (Part B).
Participants with SLE must meet EULAR/ACR 2019 criteria and have positive ANA or anti-dsDNA antibodies.
Participants with CLE must have a histologically confirmed diagnosis and active disease despite conventional therapies.
Participants must be willing and able to comply with study treatment and evaluations.

You will not qualify if you...

History or evidence of clinically significant diseases (Part A).
History of herpes zoster (shingles) or recurrent herpes simplex infections.
Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days before dosing.
History of sensitivity to ingredients of DB-2304.
Surgery within the past 3 months or plans for surgery during the study.
Active lupus nephritis or moderate-to-severe or chronic kidney disease (Part B).
Active neuropsychiatric SLE within 8 weeks prior to screening.
Active skin conditions or arthritis other than SLE that interfere with assessments.
History or ongoing malignant disease except certain fully excised skin and cervical cancers.
History of primary immunodeficiency, splenectomy, or conditions increasing infection risk.

Research Team

Sally Li

Cong Zhang

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Phase 12a Study to Assess Safety and Effects of DB-2304 Injection in Healthy Adults and Adults with Systemic or Cutaneous Lupus Erythematosus

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria