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 Adult Participants and Systemic Lupus Erythematosus Adult Participants

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• Participants who fully understand the purpose, nature, method, and potential adverse reac-tions of the study and voluntarily sign the informed consent form (ICF) and agree to partic-ipate.

• 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

• 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.

• 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.

• Currently receiving a stable SLE treatment regimen of any medication (alone or in combi-nation) for a period of at least 1 month prior to randomization.

Locations
Other Locations
Australia
Site AUS01-0
RECRUITING
Melbourne
Contact Information
Primary
Sally Li
sally.li@dualitybiologics.com
+86 13910863858
Backup
Ziyou Zhang
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2026-06-05
Participants
Target number of participants: 106
Treatments
Experimental: Dose Level 1
Experimental: Dose Level 2
Experimental: Dose Level 3
Experimental: Dose Level 4
Experimental: Dose Level 5
Experimental: Dose Level 6
Experimental: Dose Level 7
Experimental: Dose Level 8
Related Therapeutic Areas
Sponsors
Leads: DualityBio Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials