Phase 2 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Part A (Healthy Volunteers):

• You fully understand what the study involves and are willing to sign a consent form to participate
• You are a healthy man or woman between 18 and 55 years old, and your body weight falls within an acceptable range for your height (confirm with trial site for exact BMI limits)
• You have no significant health problems based on a doctor's review of your medical history, physical exam, blood tests, and heart tracing (ECG)
• You agree to use reliable birth control during the study (applies to women who could become pregnant and to men)
• You are willing and able to follow all the study requirements and attend all appointments

Part B (Patients with Lupus):

• You fully understand what the study involves and are willing to sign a consent form to participate
• You are a man or woman between 18 and 70 years old
• You have been on a stable treatment plan for your lupus for at least 1 month before joining the study
• You have been diagnosed with Systemic Lupus Erythematosus (SLE) according to recognised medical guidelines, AND have had a positive lupus blood test (ANA or anti-dsDNA), AND currently have active lupus affecting your skin
• OR you have been diagnosed with Cutaneous Lupus Erythematosus (CLE) confirmed by a skin biopsy, AND your skin lupus is still active despite trying standard treatments

Who may not be able to join:

Part A (Healthy Volunteers):

• You have a history of any significant medical condition
• You have had shingles, or you get recurring cold sores or genital herpes
• You have had any active infection (bacterial, viral, fungal, or parasitic) in the 30 days before the study starts
• You have a known allergy or sensitivity to any ingredient in the study drug (DB-2304)
• You have had surgery in the past 3 months or plan to have surgery during the study

Part B (Patients with Lupus):

• You currently have lupus affecting your kidneys, or you have moderate-to-severe or long-term kidney disease
• You have had lupus affecting your brain or mental health within the 8 weeks before screening
• You have another active skin condition or active joint disease (such as psoriasis or rheumatoid arthritis) that could interfere with how the study assessments are done
• You have a current or past history of cancer, with some exceptions for certain skin cancers that were fully removed and considered cured more than 2 years ago (confirm with trial site)
• You have a known condition that weakens your immune system, have had your spleen removed, or have any condition that makes you more prone to infections

Important: Always verify eligibility with the trial site directly before applying.