A Phase 1 Study of DB-2304 in Healthy Adults and SLE Participants

Launched by DUALITYBIO INC. · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called DB-2304 to see how safe it is and how it works in both healthy adults and adults with Systemic Lupus Erythematosus (SLE), a disease that can cause inflammation and damage to various parts of the body. The trial is currently recruiting participants aged 18 to 70, and there are specific criteria that individuals must meet to qualify. For healthy participants, they should be in good health and not have any significant medical issues. For those with SLE, they must have a confirmed diagnosis and be stable on their current treatment for at least a month.

Participants in this study can expect to receive either the new medication or a placebo (a harmless substitute) during the trial. The study will involve several visits where researchers will monitor their health, check for any side effects, and understand how the body processes the medication. It’s important for potential participants to know that they will need to follow specific guidelines and that their participation will contribute to understanding how this new treatment might help people with lupus in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Part A):
• • 1. Participants who fully understand the purpose, nature, method, and potential adverse reac-tions of the study and voluntarily sign the informed consent form (ICF) and agree to partic-ipate.
• • 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. 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.
• • 7. Currently receiving a stable SLE treatment regimen of any medication (alone or in combi-nation) for a period of at least 1 month prior to randomization.
• 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.