A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants (NCT06625671) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
United States, Australia148 participantsStarted 2024-10-04
Plain-language summary
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. 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.
. Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.
. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations
. 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.
. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations.
. Male or female participants, 18 to 70 years of age (both inclusive) on the day of signing ICF.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
TEAEs
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
2
SAEs
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
3
ECG parameters
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
4
Weight measurements
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
5
Heart Rate measurements
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
6
Pulse rate measurements
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
. Evidence or history of clinically significant diseases.
. History of herpes zoster (shingles) or recurrent herpes simplex (e.g., oral cold sores or gen-ital sores).
. Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days prior to dosing.
. History of sensitivity to any ingredients of DB-2304.
. Participants who have undergone surgery within the past 3 months or have plans for sur-gery during the study.
. Have active lupus nephritis or moderate-to-severe or chronic kidney disease
. Have active neuropsychiatric SLE within 8 weeks prior to screening
. 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.
7
Respiratory rate measurements
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B
8
Body temperature measurements
Timeframe: Up to 112 days after the study treatment administration for Part A, and up to 280 days after the first study treatment administration for Part B