NCT06625671 A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
| NCT ID | NCT06625671 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | DualityBio Inc. |
| Condition | Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2024-10-04 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 148 participants in total. It began in 2024-10-04 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous 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.
Contact & Investigator
Lily Hu
STUDY DIRECTOR
DualityBio Inc.
Frequently Asked Questions
Who can join the NCT06625671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06625671 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06625671 currently recruiting?
Yes, NCT06625671 is actively recruiting participants. Contact the research team at sally.li@dualitybiologics.com for enrollment information.
Where is the NCT06625671 trial being conducted?
This trial is being conducted at La Palma, United States, Clearwater, United States, Orlando, United States, Syracuse, United States and 3 additional locations.
Who is sponsoring the NCT06625671 clinical trial?
NCT06625671 is sponsored by DualityBio Inc.. The principal investigator is Lily Hu at DualityBio Inc.. The trial plans to enroll 148 participants.
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