Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06625671

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Site AUS01-0, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Part A):

  • 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

Inclusion criteria

(Part B):

  • 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.

9.Must have active CLE despite an adequate trial of conventional therapies.

Exclusion criteria

(Part A):

  • 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.

Exclusion criteria

(Part B):

  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

DB-2304

Drug

DB-2304

Placebo

Drug

Placebo

Prednisone

Drug

Prednisone

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cong Zhang

CONTACT

Sally Li

CONTACT

[email protected]

+86 13910863858

Sponsors and collaborators

Lead sponsor

DualityBio Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 3, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.