NCT06625671

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: DualityBio Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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)

Interventions

Type	Name	Description
DRUG	DB-2304	DB-2304
DRUG	Placebo	Placebo
DRUG	Prednisone	Prednisone

Timeline

• Start date: 2024-10-04
• Primary completion: 2026-03-23
• Completion: 2026-06-05
• First posted: 2024-10-03
• Last updated: 2025-12-18

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study