NCT03815396已完成1 期
An Open-Label, Multicenter, Phase 1 Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Intravenous Doses of Inhibrx rhAAT-Fc (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Frequency of adverse events of INBRX-101
研究概览
简要总结
This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented alpha-1 antitrypsin (AAT) serum concentration <11 μM.
- •Diagnosis of alpha-1 antitrypsin deficiency (AATD) with any allelic combination with exception of the null/null genotype.
- •For subjects in Part 2 80 and 120 mg/kg cohorts ONLY: post-bronchodilator FEV1 of at least 40% of predicted normal value.
- •For subjects in Part 2 80 and 120 mg/kg cohorts ONLY: subjects eligible for bronchoscopy per judgment of investigator.
- •Nonsmoker for at least 6 months prior to study and must remain nonsmoking for the entire study duration.
- •Adequate hepatic and renal function as defined per protocol.
- •Willing to undergo current augmentation therapy washout (if applicable) and refrain from initiating augmentation therapy, other investigational drug trials for AATD, therapy with IV immunoglobulins or monoclonal antibodies during the entire study, including follow-up.
排除标准
- •Known or suspected allergy to components of INBRX-101 (AAT or human IgG) or pdAAT.
- •Participation in any investigational drug trial within 30 days prior to this trial, or subjects receiving IV immunoglobulins or monoclonal antibodies within 30 days prior to this trial.
- •History of and/or on the waiting list for lung or liver transplant, lobectomy, or lung volume reduction surgery.
- •Acute respiratory tract infection or COPD exacerbation that required antibiotic treatment and/or increase in systemic steroid dosage within the 4 weeks prior to screening. Subjects are permitted to continue to receive steroids if the investigator judges the subject to have a history of stable dosing.
- •Subjects with ongoing or history of unstable cor pulmonale.
- •Infection with hepatitis A, B, or C or human immunodeficiency virus (HIV).
- •Active autoimmune disease or documented history of autoimmune disease that 1) required systemic steroids or immune-suppressive medications and 2) tested positive for auto-antibodies. Exception: Endocrinopathies managed with hormone replacement therapy (HRT).
- •Current substance and/or alcohol abuse with protocol defined exceptions.
- •Current narcotics abuse with protocol defined exceptions.
研究组 & 干预措施
Part 1 Single Ascending Dose
Experimental
INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
干预措施: INBRX-101/rhAAT-Fc (Drug)
Part 2 Multiple Ascending Dose
Experimental
INBRX-101 will be escalated in subjects with alpha-1 antitrypsin deficiency (AATD).
干预措施: INBRX-101/rhAAT-Fc (Drug)
结局指标
主要结局
Frequency of adverse events of INBRX-101
时间窗: Up to 7 months
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
Severity of adverse events of INBRX-101
时间窗: Up to 7 months
Severity of adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
次要结局
- Maximum observed serum concentration (Cmax) of INBRX-101(Up to 7 months)
- Half-life (T1/2) of INBRX-101(Up to 7 months)
- Area under the serum concentration time curve (AUC) of INBRX-101(Up to 7 months)
- Time to Cmax (Tmax) of INBRX-101(Up to 7 months)
- Immunogenicity of INBRX-101(Up to 7 months)
- Distribution of INBRX-101 in Bronchoalveolar Lavage Fluid (BALF)(Up to 7 months)
- Functional concentration of INBRX-101 in serum and BALF(Up to 7 months)
- Trough observed serum concentration (Ctrough) of INBRX-101(Up to 7 months)
研究者
研究点 (10)
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