A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 and ABBV-2B04 as Monotherapy or Combination Therapy in Adults With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 18
- 主要终点
- Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 and ABBV-2B04 given alone and in combination to participants with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug.
ABBV-47D11 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally.
In part A participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
详细描述
Part B of this study was not conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization.
- •Must have >= 1 symptom associated with COVID-19 with an onset of <= 8 days prior to randomization.
- •Hospitalized or plans for hospital admission due to COVID-19 at the time of randomization or not currently hospitalized and does not have plans for hospital admission at the time of randomization, but is willing to be confined for ≥ 48 hours post-dose for the purposes of participating in this research study
排除标准
- •Have an oxygen saturation (SpO2) < 88% on room air at rest for 5 minutes OR ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <= 200 mmHg at randomization.
- •Requiring high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/extracorporeal membrane oxygenation (ECMO) or anticipated impending need for high-flow nasal cannula oxygen therapy/non-invasive or invasive mechanical ventilation/ECMO.
- •Prior treatment with a SARS-CoV-2 specific monoclonal antibody or convalescent COVID-19 plasma.
研究组 & 干预措施
Part A: Group 1: ABBV-47D11 Dose A
Participants will receive ABBV-47D11 Dose A on Day 1.
干预措施: ABBV-47D11 (Drug)
Part A: Group 1: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
干预措施: Placebo for ABBV-47D11 (Drug)
Part A: Group 2: ABBV-47D11 Dose B
Participants will receive ABBV-47D11 Dose B on Day 1.
干预措施: ABBV-47D11 (Drug)
Part A: Group 2: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
干预措施: Placebo for ABBV-47D11 (Drug)
Part A: Group 3: ABBV-47D11 Dose C
Participants will receive ABBV-47D11 Dose C on Day 1.
干预措施: ABBV-47D11 (Drug)
Part A: Group 3: Placebo for ABBV-47D11
Participants will receive placebo for ABBV-47D11 on Day 1.
干预措施: Placebo for ABBV-47D11 (Drug)
Part B: Group 1: ABBV-2B04 Dose A
Participants will receive ABBV-2B04 Dose A on Day 1.
干预措施: ABBV-2B04 (Drug)
Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11
Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1.
干预措施: ABBV-47D11 (Drug)
Part B: Group 1: ABBV-2B04 Dose A + ABBV-47D11
Participants will receive ABBV-2B04 Dose A in combination with ABBV-47D11 on Day 1.
干预措施: ABBV-2B04 (Drug)
Part B: Group 1: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
干预措施: Placebo for ABBV-47D11 (Drug)
Part B: Group 1: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
干预措施: Placebo for ABBV-2B04 (Drug)
Part B: Group 2: ABBV-2B04 Dose B
Participants will receive ABBV-2B04 Dose B on Day 1.
干预措施: ABBV-2B04 (Drug)
Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11
Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1.
干预措施: ABBV-47D11 (Drug)
Part B: Group 2: ABBV-2B04 Dose B + ABBV-47D11
Participants will receive ABBV-2B04 Dose B in combination with ABBV-47D11 on Day 1.
干预措施: ABBV-2B04 (Drug)
Part B: Group 2: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
干预措施: Placebo for ABBV-47D11 (Drug)
Part B: Group 2: Placebo
Participants will receive Placebo for ABBV-2B04 followed by Placebo for ABBV-47D11 on Day 1.
干预措施: Placebo for ABBV-2B04 (Drug)
结局指标
主要结局
Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions
时间窗: Up to Day 106
Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.
Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs)
时间窗: Up to Day 106
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
次要结局
- AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR)(Baseline (Day 1) through Day 29)
- Time to Cmax (Tmax) of ABBV-2B04(Up to Day 85)
- Time to Negative SARS-CoV-2 by RT-PCR(Up to Day 29)
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-2B04(Up to Day 85)
- Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-2B04(Up to Day 85)
- Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11(Up to Day 29)
- AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11(Up to Day 85)
- Detection of Neutralizing Anti-Drug Antibodies (nADA) for ABBV-47D11(Up to Day 85)
- Negative SARS-CoV-2 RNA by RT-PCR(Up to Day 15)
- Time to Cmax (Tmax) of ABBV-47D11(Up to Day 85)
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11(Up to Day 85)
- Detection of Anti-Drug Antibodies (ADA) for ABBV-47D11(Up to Day 85)
- Maximum Observed Serum Concentration (Cmax) of ABBV-2B04(Up to Day 85)
- Maximum Observed Serum Concentration (Cmax) of ABBV-47D11(Up to Day 85)
- Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-2B04(Up to Day 29)
- AUC From Time 0 to Infinity (AUCinf) of ABBV-2B04(Up to Day 85)
- Detection of Anti-Drug Antibodies (ADA) for ABBV-2B04(Up to Day 85)