A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants

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

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Drug: Prednisone; Drug: DB-2304

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sally Li; Phone Number: +86 13910863858; Email: sally.li@dualitybiologics.com
• Study Contact Backup: Name: Cong Zhang

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Completed
      • Site AUS01-0
• United States
  • California
    • La Palma, California, United States, 90623
      • Recruiting
      • US06-0
  • Florida
    • Clearwater, Florida, United States, 33765
      • Recruiting
      • US03-0
    • Orlando, Florida, United States, 32808
      • Recruiting
      • US05-0
  • New York
    • Syracuse, New York, United States, 13210
      • Not yet recruiting
      • US08-0
  • Texas
    • Irving, Texas, United States, 75061
      • Recruiting
      • US04-0
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • US02-0

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria (Part B):

1. Have active lupus nephritis or moderate-to-severe or chronic kidney disease
2. Have active neuropsychiatric SLE within 8 weeks prior to screening
3. 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.
4. 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.
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Level 1	Drug: Placebo; Placebo; Drug: Prednisone; Prednisone; Drug: DB-2304; DB-2304
Experimental: Dose Level 2	Drug: Placebo; Placebo; Drug: Prednisone; Prednisone; Drug: DB-2304; DB-2304
Experimental: Dose Level 3	Drug: Placebo; Placebo; Drug: Prednisone; Prednisone; Drug: DB-2304; DB-2304
Experimental: Dose Level 4	Drug: Placebo; Placebo; Drug: Prednisone; Prednisone; Drug: DB-2304; DB-2304
Experimental: Dose Level 5	Drug: Placebo; Placebo; Drug: Prednisone; Prednisone; Drug: DB-2304; DB-2304
Experimental: Dose Level 6	Drug: Placebo; Placebo; Drug: DB-2304; DB-2304
Experimental: Dose Level 7	Drug: Placebo; Placebo; Drug: DB-2304; DB-2304
Experimental: Dose Level 8	Drug: Placebo; Placebo; Drug: DB-2304; DB-2304

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAEs	Treatment-emergent adverse events	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	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.	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: DualityBio Inc.
• Investigators: Study Director: Lily Hu, DualityBio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Prednisone
• Other Study ID Numbers: DB-2304-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No