A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body

Официальное название

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

Обзор

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).

Вмешательства

• Препарат HBM7020
  Liquid formulation, administered through intravenous infusion

Первичные конечные точки

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48 [Срок оценки: 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 [Срок оценки: Up to Week 24]
• Number of Participants With Dose limiting AE Evaluation During Dose Escalation [Срок оценки: Up to Day 15]
• Number of Participants With Clinically Significant Changes in Vital Signs [Срок оценки: Up to Week 24]
• Number of Participants With Clinically Significant Changes in Physical Examination Findings [Срок оценки: Up to Week 24]
• Change From Baseline in Serum Interleukin-6 (IL-6) [Срок оценки: Up to Week 20]
• Change From Baseline in Serum Tumour Necrosis Factor-Alpha (TNF-α) [Срок оценки: Up to Week 20]
• Change From Baseline in Serum Interferon-Gamma (IFN-γ) [Срок оценки: Up to Week 20]
• Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP) [Срок оценки: Up to Week 20]
• Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR) [Срок оценки: Up to Week 20]

Вторичные конечные точки (5)

• Area Under the Concentration-Time Curve From Time Zero to Last Observable Concentration (AUCt) of HBM7020 [Срок оценки: 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 [Срок оценки: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)]
• Maximum Observed Plasma Concentration (Cmax) of HBM7020 [Срок оценки: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)]
• Time to Maximum Observed Plasma Concentration (tmax) of HBM7020 [Срок оценки: Pre dose on Day 1 up to completion of pharmacokinetic assessments (Day 29)]
• Number of Participants With Anti-Drug Antibodies (ADA) to HBM7020 [Срок оценки: Up to Week 24]

Критерии участия

Key Inclusion Criteria 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.

Key Exclusion Criteria 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07649265 · 365-201-00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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