Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
Conditions
Brief summary
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
Interventions
DRUGDB-2304
DB-2304
DRUGPlacebo
Placebo
DRUGPrednisone
Prednisone
Sponsors
DualityBio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEAEs | 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 | Treatment-emergent adverse events |
| SAEs | 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 | serious adverse events |
| ECG parameters | 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 | 12-lead electrocardiograms parameters including HR, PR, QT intervals, QTcF intervals for Fredericia's formula-QT corrected interval), and QRS duration should be determined. |
| Weight measurements | 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 | Change and Rate of Change from Baseline in weight |
| Heart Rate measurements | 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 | Change and Rate of Change from Baseline in heart rate |
| Pulse rate measurements | 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 | Change and Rate of Change from Baseline in pulse rate |
| Respiratory rate measurements | 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 | Change and Rate of Change from Baseline in respiratory rate |
| Body temperature measurements | 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 | Change and Rate of Change from Baseline in body temperature |
Countries
Australia, United States
Contacts
CONTACTSally Li
CONTACTCong Zhang
STUDY_DIRECTORLily Hu
DualityBio Inc.
Outcome results
None listed