DB-2304 for Systemic Lupus Erythematosus or Cutaneous Lupus

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

Recruiting Phase 1 Phase 2 Interventional Study
Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
148 (estimated)
Sponsor
DualityBio Inc. · Industry
Who this trial is looking for

This trial is looking for healthy adults and adults with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE) to participate in a study of a new treatment called DB-2304. Participants will need to complete certain tests and follow study guidelines.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 55 years old for Part A or 18 and 70 years old for Part B.
  • I fully understand the study and agree to participate.
  • I am a healthy adult or have SLE or CLE.
  • I am willing to follow the study treatment plan.
  • I have been on a stable SLE/CLE treatment for at least 1 month (Part B only).
  • I meet the criteria for SLE or have been diagnosed with CLE (Part B only).

You may not be able to join if

  • I have clinically significant diseases.
  • I have had shingles or recurrent cold sores.
  • I have an active infection within 30 days before starting the study.
  • I had surgery in the past 3 months or plan to have surgery during the study.
  • I have active lupus nephritis or kidney disease (Part B only).
  • I have active neuropsychiatric SLE within the last 8 weeks (Part B only).
  • I have any ongoing malignant disease except for certain skin cancers.
  • I have a primary immunodeficiency or a condition increasing infection risk.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
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) o…
Contacts

Sally Li

+86 13910863858

sally.li@dualitybiologics.com

CONTACT

Cong Zhang

CONTACT