A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Acne Vulgaris (AV).
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in inflammatory lesion counts
研究概览
简要总结
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.
详细描述
The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understand the research procedure of this study and provide written informed consent;
- •Male or female, age 18 years or greater;
- •Diagnosed with mild to moderate facial acne vulgaris;
- •Throughout the study period, participants must refrain from using concomitant acne therapies.
- •5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.
排除标准
- •1. Participants with known hypersensitivity to HB0043 or any of its excipients;
- •Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.
- •3. Participant has any facial skin disease other than common acne.
- •Presence of other active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis;
- •Participant has any other active skin disease or condition that may interfere with the assessment of acne vulgaris;
- •History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ);
- •History of recurrent or recent serious infection;
- •Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection;
- •Pregnant or lactating women;
- •Any reason why, in the opinion of the investigator, the patient should not participate.
研究组 & 干预措施
HB0043
Participants randomized to Arm 1 will receive HB0043 via subcutaneous injection biweekly from Week 0 to Week 14.
干预措施: HB0043 (Drug)
Placebo
Participants randomized to Arm 2 will receive placebo via subcutaneous injection biweekly from Week 0 to Week 6, followed by HB0043 via subcutaneous injection biweekly from Week 8 to Week 14.
干预措施: HB0043 (Drug)
Placebo
Participants randomized to Arm 2 will receive placebo via subcutaneous injection biweekly from Week 0 to Week 6, followed by HB0043 via subcutaneous injection biweekly from Week 8 to Week 14.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in inflammatory lesion counts
时间窗: Week 16
Absolute change from Baseline in the number of inflammatory acne lesions
Investigator's global assessment (IGA) - change from Baseline
时间窗: Week 16
Absolute change in IGA score from Baseline \[scores: 0-4; 0=clear, 4=severe\]
次要结局
- Investigator's global assessment (IGA) - percentage of subjects with improvement(Week 2, 4, 8, 12, 16)
- Change in inflammatory lesion counts(Week 16)
- Incidence of AEs and serious adverse events (SAEs))(Baseline to week 16)