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

DualityBio

Status and phase: Enrolling; Phase 1

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Drug: Placebo; Drug: Prednisone; Drug: DB-2304

Study type: Interventional

Funder types: Industry

Identifiers

NCT06625671

DB-2304-101

Details and patient eligibility

About

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

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Part A):

1. 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.
2. 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.
3. 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.
4. Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.
5. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations

Inclusion Criteria (Part B):

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. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations.
3. Male or female participants, 18 to 70 years of age (both inclusive) on the day of signing ICF.
4. Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
5. History or presence at Screening of positive antinuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
6. At screening have active lupus skin disease defined by the SELENA-SLEDAI at screening and randomization.
7. 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.

Exclusion Criteria (Part A):

1. Evidence or history of clinically significant diseases.
2. History of herpes zoster (shingles) or recurrent herpes simplex (e.g., oral cold sores or gen-ital sores).
3. Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days prior to dosing.
4. History of sensitivity to any ingredients of DB-2304.
5. Participants who have undergone surgery within the past 3 months or have plans for sur-gery during the study.

Exclusion Criteria (Part B):

1. Have active lupus nephritis or moderate-to-severe or chronic kidney disease
2. Have active neuropsychiatric SLE within 8 weeks prior to screening
3. Any active skin conditions or active arthritis other than SLE that may interfere with skin or arthritis assessments (e.g., psoriasis, non-LE skin lesions, non-LE alopecia areata, drug-induced lupus, rheumatoid arthritis) at screening.
4. History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies with the exception of basal cell carcinomas and squamous cell carcinomas and carcinoma in situ of the cervix that have been completely excised and considered cured >2 years prior to Screening.
5. Known history of a primary immunodeficiency (e.g., common variable immunodeficiency syndrome), splenectomy, or any underlying condition that predisposes the participant to infection.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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106 participants in 8 patient groups

Dose Level 1

Experimental group

Treatment:

Drug: Prednisone

Drug: DB-2304

Drug: Placebo

Dose Level 2

Experimental group

Treatment:

Drug: Prednisone

Drug: DB-2304

Drug: Placebo

Dose Level 3

Experimental group

Treatment:

Drug: Prednisone

Drug: DB-2304

Drug: Placebo

Dose Level 4

Experimental group

Treatment:

Drug: Prednisone

Drug: DB-2304

Drug: Placebo

Dose Level 5

Experimental group

Treatment:

Drug: Prednisone

Drug: DB-2304

Drug: Placebo

Dose Level 6

Experimental group

Treatment:

Drug: DB-2304

Drug: Placebo

Dose Level 7

Experimental group

Treatment:

Drug: DB-2304

Drug: Placebo

Dose Level 8

Experimental group

Treatment:

Drug: DB-2304

Drug: Placebo