NCT06832722招募中1 期
Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b/2a Trial to Investigate Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Invobenitug Also Known as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations.
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 41
- 主要终点
- Reported number of treatment-emergent adverse events from start of Procizumab administration up until the last follow-up visit after Procizumab administration
研究概览
简要总结
The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Signed informed consent.
- •Diagnosis of CS based on the following entry criteria:
- •Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg
- •Lactate ≥ 2.0 mmol/L
- •High DPP3 concentration ≥ 30 ng/mL
- •Etiology of CS must be one of the following: ACS, septic (according to SEPSIS 3 criteria) or adHF origin
排除标准
- •Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP.
- •Patients being longer than 24 hours in the ICU at the time of randomization.
- •Patients below the age of 18 or above 80 years.
- •Patients receiving Ang II and/or levosimendan
- •Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.
- •Stroke or transient ischemic attack within the last 3 months.
- •SCAI Shock Stage E.
- •Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).
- •Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.
- •Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial.
- •Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US).
- •CPR lasting more than 15 minutes and/or the patient is not conscious at randomization.
- •Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.
- •Pericardial constriction.
- •Sustained SBP > 120 mmHg during the hour prior to randomization.
- •Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score >30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary failure and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR <20 ml/min/1.73 m2 or chronic dialysis.
- •Patients with untreated sepsis.
- •Patients with valvular heart diseases as the primary cause of cardiogenic shock.
- •Other known causes of shock, namely
- •Hypovolemia
- •Anaphylaxis
- •Intoxication (e.g., drug-induced shock)
- •Dynamic left ventricular outflow tract obstruction
- •isolated right heart failure, including cardiac tamponade and/or pulmonary embolism
- •Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture
- •Inappropriate pacing or shock resulting from ICD malfunction
- •Patients who have severe immune suppression: recent (<3 months) chemotherapy and/or severe neutropenia (neutrophile count <500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (<3 months) organ transplantation.
- •Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed.
- •Women who are pregnant or breastfeeding.
- •Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization.
- •Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only).
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Invobenitug also known as Invobenitug (AK1967) 10mg/kg body weight
Active Comparator
干预措施: AK1967 (Invobenitug also known as Procizumab) (Drug)
结局指标
主要结局
Reported number of treatment-emergent adverse events from start of Procizumab administration up until the last follow-up visit after Procizumab administration
时间窗: 30 days
Reported number of treatment-emergent adverse events from start of Invobenitug administration up until the last follow-up visit after Invobenitug administration
时间窗: 30 days
次要结局
- Pharmacokinetics defined as plasma-time concentration of procizumab(30 days)
- Pharmacodynamics defined as cDPP3 concentration(30 days)
- Pharmcodynamics defined as cDPP3 activity(30 days)
- Pharmacokinetics defined as plasma-time concentration of invobenitug(30 days)
研究者
研究点 (41)
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