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

ConditionSystemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDualityBio Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • DB-2304

    Drug

    DB-2304

  • Placebo

    Drug

    Placebo

  • Prednisone

    Drug

    Prednisone

Treatment groups

148 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Dose Level 1Experimental treatment 3 interventions
Group B: Dose Level 2Experimental treatment 3 interventions
Group C: Dose Level 3Experimental treatment 3 interventions
Group D: Dose Level 4Experimental treatment 3 interventions
Group E: Dose Level 5Experimental treatment 3 interventions
Group F: Dose Level 6Experimental treatment 2 interventions
Group G: Dose Level 7Experimental treatment 2 interventions
Group H: Dose Level 8Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

TEAEs

Treatment-emergent adverse events

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
2

SAEs

serious adverse events

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
3

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.

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
4

Weight measurements

Change and Rate of Change from Baseline in weight

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DualityBio Inc.

Lead sponsor

Source ClinicalTrials.gov
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