A Phase 1 Open-Label, Multicenter Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HBM7020 in Healthy Adult Participants and Adults With Seropositive Autoimmune Disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 63
- 主要终点
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
研究概览
简要总结
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Healthy Participants (Part 1)
- •Participants who are of non-childbearing potential or are using acceptable contraception.
- •Body mass index (BMI) and body weight within an acceptable range.
- •Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.
- •Key Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1)
- •BMI and body weight within an acceptable range.
- •Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.
- •Key Disease-Specific Inclusion Criteria for Patient Participants (Part 1)
- •Confirmed autoimmune disease with appropriate supporting autoantibody findings.
- •Stable background therapy prior to dosing.
- •Active moderate to severe disease consistent with protocol-defined disease activity criteria for:
- •Systemic lupus erythematosus (SLE)
- •Systemic sclerosis (SSc)
- •Rheumatoid arthritis (RA)
- •Sjögren's disease (SjD)
- •Key Inclusion Criteria for Rescreening Participants (Part 2)
- •Meets Part 1 disease-agnostic inclusion criteria.
- •Stable background autoimmune therapy prior to dosing.
- •Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.
排除标准
- •for Parts 1 and 2
- •Pregnant or breastfeeding participants.
- •Recent vaccination within protocol-defined timelines.
- •Clinically significant medical history or abnormal physical examination findings.
- •Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.
- •Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.
- •Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.
研究组 & 干预措施
Part 1
Participants will receive HBM7020 in sequential dose-escalation cohorts in Part 1.
干预措施: HBM7020 (Drug)
Part 2
Participants may receive optional retreatment of HBM7020 in Part 2 if eligible.
干预措施: HBM7020 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48
时间窗: Up to Week 48
Number of Participants With Signs Characteristic of Cytokine Release Syndrome (CRS), Immune Related Reaction (IRR), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Including Immunosuppression-Related Infection
时间窗: Up to Week 24
Number of Participants With Dose limiting AE Evaluation During Dose Escalation
时间窗: Up to Day 15
Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Up to Week 24
Number of Participants With Clinically Significant Changes in Physical Examination Findings
时间窗: Up to Week 24
Change From Baseline in Serum Interleukin-6 (IL-6)
时间窗: Up to Week 20
Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α)
时间窗: Up to Week 20
Change From Baseline in Serum Interferon-Gamma (IFN-γ)
时间窗: Up to Week 20
Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)
时间窗: Up to Week 20
Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)
时间窗: Up to Week 20
Change From Baseline in Serum Ferritin
时间窗: Up to Week 20
Change From Baseline in Serum Immunoglobulin G (IgG)
时间窗: Up to Week 20
次要结局
- Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020(Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29))
- Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of HBM7020(Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29))
- Maximum Observed Plasma Concentration (Cmax) of HBM7020(Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29))
- Time to Maximum Observed Plasma Concentration (tmax) of HBM7020(Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29))
- Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020(Up to Week 24)