A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDualityBio Inc.
About this trial
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DB-2304
- Placebo
- Prednisone
Treatment groups
148 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov