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

Phase 1

Recruiting

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: DB-2304; Drug: Placebo; Drug: Prednisone

• Registration Number: NCT06625671
• Lead Sponsor: DualityBio Inc.

Brief Summary

A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single Ascending Dose and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DB-2304 Injection in Healthy Adults and Systemic Lupus Erythematosus Adult Participants

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Study Start: 2024-10-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-03-23
• Study Completion: 2026-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Level 1	DB-2304	-
Dose Level 1	Placebo	-
Dose Level 2	Prednisone	-
Dose Level 4	DB-2304	-
Dose Level 6	Placebo	-
Dose Level 1	Prednisone	-
Dose Level 2	DB-2304	-
Dose Level 3	Placebo	-
Dose Level 3	Prednisone	-
Dose Level 4	Prednisone	-
Dose Level 2	Placebo	-
Dose Level 3	DB-2304	-
Dose Level 4	Placebo	-
Dose Level 5	DB-2304	-
Dose Level 5	Placebo	-
Dose Level 5	Prednisone	-
Dose Level 6	DB-2304	-
Dose Level 7	DB-2304	-
Dose Level 7	Placebo	-
Dose Level 8	DB-2304	-
Dose Level 8	Placebo	-

Primary Outcome Measures

Name	Time	Method
TEAEs	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	Treatment-emergent adverse events
SAEs	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	serious adverse events
ECG parameters	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	12-lead electrocardiograms parameters including HR, PR, QT intervals, QTcF intervals for Fredericia's formula-QT corrected interval), and QRS duration should be determined.
Weight measurements	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	Change and Rate of Change from Baseline in weight
Heart Rate measurements	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	Change and Rate of Change from Baseline in heart rate
Pulse rate measurements	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	Change and Rate of Change from Baseline in pulse rate
Respiratory rate measurements	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	Change and Rate of Change from Baseline in respiratory rate
Body temperature measurements	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	Change and Rate of Change from Baseline in body temperature

Trial Locations

Locations (1)

Site AUS01-0; 🇦🇺 Melbourne, Victoria, Australia