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

NCT06625671 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DB-2304-101
• Study Type: interventional
• Target: 148
• Locations: 2 countries
• Sites: 4

Brief Summary

A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (8)

• TEAEs

  Treatment-emergent adverse events

  Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B

• SAEs

  serious adverse events

  Up to 112 days after last study treatment administration for Part A, and up to 196 days after last 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 last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B

• Weight measurements

  Change and Rate of Change from Baseline in weight

  Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B

• Heart Rate measurements

  Change and Rate of Change from Baseline in heart rate

  Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B

• Pulse rate measurements

  Change and Rate of Change from Baseline in pulse rate

  Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B

• Respiratory rate measurements

  Change and Rate of Change from Baseline in respiratory rate

  Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B

• Body temperature measurements

  Change and Rate of Change from Baseline in body temperature

  Up to 112 days after last study treatment administration for Part A, and up to 196 days after last study treatment administration for Part B

Study Arms (8)

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

Interventions

DB-2304 DRUG

DB-2304

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5; Dose Level 6; Dose Level 7; Dose Level 8

Placebo DRUG

Placebo

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5; Dose Level 6; Dose Level 7; Dose Level 8

Prednisone DRUG

Prednisone

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• \. History or presence at Screening of positive antinuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
• \. 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.
• Must have active CLE despite an adequate trial of conventional therapies.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• DualityBio Inc.: lead

Study Sites (4)

US03-0

Clearwater, Florida, 33765, United States

RECRUITING

US04-0

Irving, Texas, 75061, United States

RECRUITING

US02-0

San Antonio, Texas, 78215, United States

RECRUITING

Site AUS01-0

Melbourne, Victoria, 3004, Australia

COMPLETED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lily Hu

  DualityBio Inc.

  STUDY DIRECTOR

Central Study Contacts

Sally Li

CONTACT

+86 13910863858; sally.li@dualitybiologics.com

Cong Zhang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 3, 2024
• Study Start: October 4, 2024
• Primary Completion: March 23, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (3); AU (1)