Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus ErythematosusPhase 1/2NCT06625671
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
A Phase 1/2 study testing DB-2304 and Prednisone in people with Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus, run by DualityBio Inc. at 7 sites in 2 countries.
Trial summary
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
- What is being tested?
- DB-2304 and Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 4 Oct 2024to 30 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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
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- 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.
- 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.
- 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.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Cong Zhang contact
7 sites in 2 countries
United States6 sites, 6 recruiting
- Recruiting
US03-0
Clearwater, Florida, 33765
- Recruiting
US04-0
Irving, Texas, 75061
- Recruiting
US06-0
La Palma, California, 90623
- Recruiting
US05-0
Orlando, Florida, 32808
- Recruiting
US02-0
San Antonio, Texas, 78215
- Not yet recruiting
US08-0
Syracuse, New York, 13210
About this study
Official title: A Randomized, Double-Blind, Phase 1/2a Study to Evaluate the Safety, Tolerability, PK and PD of DB-2304 for Injection in Healthy Adult Participants and Participants With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- Being tested
- DB-2304, Placebo, Prednisone
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-2304Drug
DB-2304
PlaceboDrug
Placebo
PrednisoneDrug
Prednisone
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo; Drug: Prednisone |
| Dose Level 2 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo; Drug: Prednisone |
| Dose Level 3 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo; Drug: Prednisone |
| Dose Level 4 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo; Drug: Prednisone |
| Dose Level 5 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo; Drug: Prednisone |
| Dose Level 6 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo |
| Dose Level 7 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo |
| Dose Level 8 | Experimental | Not described Receives: Drug: DB-2304; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
Treatment-emergent adverse events
Measured: 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
SAEs
serious adverse events
Measured: 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
ECG parameters
12-lead electrocardiograms parameters including HR, PR, QT intervals, QTcF intervals for Fredericia's formula-QT corrected interval), and QRS duration should be determined.
Measured: 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
Weight measurements
Change and Rate of Change from Baseline in weight
Measured: 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
Heart Rate measurements
Change and Rate of Change from Baseline in heart rate
Measured: 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
Pulse rate measurements
Change and Rate of Change from Baseline in pulse rate
Measured: 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
Respiratory rate measurements
Change and Rate of Change from Baseline in respiratory rate
Measured: 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
Body temperature measurements
Change and Rate of Change from Baseline in body temperature
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start4 Oct 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by DualityBio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DualityBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lily Hu, Study director, DualityBio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625671
- Sponsor's protocol ID
- DB-2304-101
- Status last verified
- May 2026
- First submitted
- 20 Sep 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 1/2a Study to Evaluate the Safety, Tolerability, PK and PD of DB-2304 for Injection in Healthy Adult Participants and Participants With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06625671
- Acronym / sponsor ID
- DB-2304-101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- DualityBio Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: DB-2304, Drug: Placebo, Drug: Prednisone |
| Dose Level 2 | Experimental | Drug: DB-2304, Drug: Placebo, Drug: Prednisone |
| Dose Level 3 | Experimental | Drug: DB-2304, Drug: Placebo, Drug: Prednisone |
| Dose Level 4 | Experimental | Drug: DB-2304, Drug: Placebo, Drug: Prednisone |
| Dose Level 5 | Experimental | Drug: DB-2304, Drug: Placebo, Drug: Prednisone |
| Dose Level 6 | Experimental | Drug: DB-2304, Drug: Placebo |
| Dose Level 7 | Experimental | Drug: DB-2304, Drug: Placebo |
| Dose Level 8 | Experimental | Drug: DB-2304, Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-2304DB-2304 | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8 |
| PlaceboPlacebo | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5, Dose Level 6, Dose Level 7, Dose Level 8 |
| PrednisonePrednisone | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4, Dose Level 5 |
Primary outcome
TEAEs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cong Zhang contact
Lily Hu study director
DualityBio Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DB-2304 and Prednisone in people with Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus, run by DualityBio Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sally Li (+86 13910863858, sally.li@dualitybiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAEs (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.