A Phase 1 Single Ascending Dose Study of a Recombinant Hyperimmune Polyclonal Antibody Against SARS CoV-2 (GIGA-2050) in Patients Hospitalized With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single ascending IV dose administrations of GIGA-2050 in patients hospitalized with COVID-19.
详细描述
This is a Phase 1, first in human (FIH) study utilizing a 3+3 design to assess the safety and pharmacology of single ascending doses (SAD) of GIGA-2050 in patients hospitalized with confirmed COVID-19. Participants will receive a single intravenous (IV) infusion dose of GIGA-2050 and followed for safety, pharmacology and efficacy assessments during hospitalization, after discharge (if applicable), and through study discontinuation or end of study visit (Day 56).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is ≥ 18 years of age.
- •Positive result of a SARS CoV-2 RNA diagnostic test result ≤48 hours before enrollment, warranting hospital admission as per Investigator's judgement.
- •COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan).
- •Requires oxygen supplementation with FIO2 approximately 30% or greater administered by nasal cannula, mask, or NIV.
- •Participants can be on other medication on-label to treat COVID-19 respiratory disease that the Investigator deems clinically relevant in combination with the study drug, including corticosteroids. Passage of 24 hours after administration of the EUA drug will be required prior to dosing GIGA-
- •Men or non-lactating female participants who are surgically sterile or post-menopausal, or a Woman of Childbearing Potential (WCBP) with a negative pregnancy test at screening willing to use highly effective contraception methods.
排除标准
- •Acute respiratory failure requiring invasive mechanical ventilation or ECMO at enrollment.
- •Systolic Blood Pressure (SBP) <110 mmHg or heart rate >120 bpm.
- •Pre-existing heart failure or unstable angina or myocardial infarction in the last month prior to screening.
- •Pre-existing chronic respiratory condition(s).
- •Evidence of acute kidney injury, increase of serum creatinine of ≥1.5 x baseline, or urine output of <0.5mL/kg/hr sustained for at least 6 hours once volume repleted.
- •Aspartate aminotransferase (AST) ≥2.5 x ULN, alanine aminotransferase (ALT) ≥2.5 x ULN, and/or total bilirubin >1.5 x ULN, or severe hepatic impairment.
- •Known systemic hypersensitivity to recombinant antibody therapies.
- •Female participant who is pregnant.
- •Participant is expected to transfer to a non-investigative facility from the investigation site and cannot be monitored for compliance with protocol-required safety monitoring procedures.
- •Participants who are currently participating or have participated in another clinical trial within 30 days prior to screening.
研究组 & 干预措施
5 mg GIGA-2050 per kg BW
Participants will receive a single IV infusion of 5 mg GIGA-2050 per kg BW
干预措施: GIGA-2050 (Drug)
15 mg GIGA-2050 per kg BW
Participants will receive a single IV infusion of 15 mg GIGA-2050 per kg BW, or as determined by SRC review
干预措施: GIGA-2050 (Drug)
50 mg GIGA-2050 per kg BW
Participants will receive a single IV infusion of 50 mg GIGA-2050 per kg BW, or as determined by SRC review
干预措施: GIGA-2050 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Day 1 up to Day 56
Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence of dose limiting toxicities (DLTs)
时间窗: Day 1 up to Day 3
Frequency of DLTs at each dose level
Incidence of infusion-related reactions (IRR) and hypersensitivity reactions
时间窗: Day 1 through Day 2
Frequency of IRR and hypersensitivity reactions
Change from baseline of vital signs, physical examination, and clinical laboratory assessments
时间窗: Day 1 up to Day 56
Numeric summaries of all observed findings and changes for vital signs, laboratory assessments, physical examinations, and ECG
次要结局
- Pharmacological evaluation of single doses of GIGA-2050(Day 1 up to Day 28)