Testing DB-2304 in healthy adults and patients with lupus

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

This study is testing a new drug called DB-2304 in healthy adults and people with lupus to see how safe it is and how it works in the body.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: DualityBio Inc. (Industry-sponsored)
• Locations: 4 sites (Clearwater, Florida and 3 other locations)
• Trial ID: NCT06625671 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of DB-2304 through a randomized, double-blind, placebo- and positive-controlled design. It involves both healthy adults and participants with systemic lupus erythematosus (SLE) to assess how the drug behaves in the body and its effects. Participants will receive either the drug, a placebo, or prednisone in single and multiple ascending doses. The study aims to gather important data on the drug's effects and safety profile.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 55 and adults diagnosed with systemic lupus erythematosus.

Not a fit: Patients with significant health issues or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients with systemic lupus erythematosus.

How similar studies have performed: Other studies have shown promise with similar approaches in evaluating new treatments for systemic lupus erythematosus.

Eligibility criteria

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-lead ECG.
4. Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.
5. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations

Inclusion Criteria (Part B):

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. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations.
3. Male or female participants, 18 to 70 years of age (both inclusive) on the day of signing ICF.
4. Currently receiving a stable SLE/CLE treatment regimen of any medication for a period of at least 1 month prior to randomization.

For SLE： 4. Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.

5\. History or presence at Screening of positive antinuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.

6\. At screening have active lupus skin disease defined by the SELENA-SLEDAI at screening and randomization.

For CLE： 8. Must have diagnosis of CLE that has been histologically confirmed, with or without systemic LE manifestations.

9.Must have active CLE despite an adequate trial of conventional therapies.

Exclusion Criteria (Part A):

1. Evidence or history of clinically significant diseases.
2. History of herpes zoster (shingles) or recurrent herpes simplex (e.g., oral cold sores or gen-ital sores).
3. Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days prior to dosing.
4. History of sensitivity to any ingredients of DB-2304.
5. Participants who have undergone surgery within the past 3 months or have plans for sur-gery during the study.

Exclusion Criteria (Part B):

1. Have active lupus nephritis or moderate-to-severe or chronic kidney disease
2. Have active neuropsychiatric SLE within 8 weeks prior to screening
3. Any active skin conditions or active arthritis other than SLE that may interfere with skin or arthritis assessments (e.g., psoriasis, non-LE skin lesions, non-LE alopecia areata, drug-induced lupus, rheumatoid arthritis) at screening.
4. History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies with the exception of basal cell carcinomas and squamous cell carcinomas and carcinoma in situ of the cervix that have been completely excised and considered cured \>2 years prior to Screening.
5. Known history of a primary immunodeficiency (e.g., common variable immunodeficiency syndrome), splenectomy, or any underlying condition that predisposes the participant to infection.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Clearwater, Florida and 3 other locations

• Us03-0 — Clearwater, Florida, United States (Recruiting)
• Us04-0 — Irving, Texas, United States (Recruiting)
• Us02-0 — San Antonio, Texas, United States (Recruiting)
• Site AUS01-0 — Melbourne, Victoria, Australia (Completed)

Study contacts

• Study coordinator: Sally Li

Conditions Systemic Lupus Erythematosus