A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Intranasal Plus Intraoral IGM-6268 in Healthy Adults and Patients With Mild to Moderate COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0
研究概览
简要总结
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers and in outpatients with mild-moderate COVID-19. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once, or once or twice each day for 5 days.
详细描述
IGM-6268 is an engineered Immunoglobulin M (IgM) antibody that specifically targets the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. This humanized pentameric IgM antibody has 10 binding sites to the spike protein and a J-chain to enable the formation of IgM pentamers.
IGM-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate COVID-19. The primary mechanism of action of IGM-6268 is to block the binding of the SARS-CoV-2 RBD on the spike protein to human angiotensin converting enzyme 2 (hACE2), the cellular receptor for SARS-CoV-2. By blocking this binding, IGM 6268 neutralizes the infectivity of the virus.
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
- Double (Participant, Investigator)
盲法说明
Double-blinded study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
- •Has a body mass index (BMI) < 35 kg/m
- •Is healthy as determined by medical history and physical examination
- •Agrees to use contraception through 3 months after the last dose of IGM-6268
排除标准
- •Receipt of any COVID-19 vaccine during this study and follow-up period
- •Prior positive SARS-CoV2 test
- •Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
- •Use of any nasally administered drug
- •Mild-Moderate COVID Patients
- •Inclusion Criteria:
- •Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
- •Agrees to use contraception through 3 months after the last dose of IGM-6268
- •Agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol.
- •Signs and symptoms of mild to moderate COVID-19 but not requiring hospitalization
- •Has a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-authorized antigen or NAAT diagnostic assay during the period of 72 hours prior to enrollment.
- •Exclusion Criteria:
- •Receipt of any COVID-19 vaccine during this study and follow-up period
- •Receipt of remdisivir, antiviral antibody treatment (plasma or Mabs), immosuppressive therapies, or cytokine-targeted anti-inflammatory drugs
- •Concurrent use of drugs not approved for use in COVID-19 patients (e.g., ivermectin, chloroquine/hydroxychloroquine, budesonide).
- •Co-morbidities including but not limited to hypertension, cardiovascular disease, diabetes (Type 1 or 2), chronic kidney disease, or asthma
- •Subject is considered to be in their last few weeks of life prior to this acute illness
- •Cancer within the last 5 years except stable prostate cancer and basal cell carcinoma
- •Hepatitis B virus (HBV), hepatitis C virus (HCV), or uncontrolled human immunodeficiency virus (HIV) infection
- •Influenza or confirmed or suspected pulmonary or systemic bacterial infection
- •Receipt of any COVID-19 vaccine during this study and follow-up period
- •Use of any nasally administered drug
研究组 & 干预措施
Cohort 2
In Cohort 2, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: IGM-6268 (Drug)
Sentinel
In the Sentinel Cohort, healthy volunteers will be randomized to receive intranasal and intraoral administration of 1 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: IGM-6268 (Drug)
Sentinel
In the Sentinel Cohort, healthy volunteers will be randomized to receive intranasal and intraoral administration of 1 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: Placebo (Drug)
Cohort 1
In Cohort 1, healthy volunteers will be randomized to receive intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: IGM-6268 (Drug)
Cohort 1
In Cohort 1, healthy volunteers will be randomized to receive intranasal and intraoral administration of 3.75 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: Placebo (Drug)
Cohort 2
In Cohort 2, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: Placebo (Drug)
Cohort 3
In Cohort 3, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.
干预措施: IGM-6268 (Drug)
Cohort 3
In Cohort 3, healthy volunteers will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.
干预措施: Placebo (Drug)
Cohort 4
In Cohort 4, mild-moderate Covid patients will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: IGM-6268 (Drug)
Cohort 4
In Cohort 4, mild-moderate Covid patients will be randomized to receive intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once per day for 5 days.
干预措施: Placebo (Drug)
Cohort 5
In Cohort 5, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.
干预措施: IGM-6268 (Drug)
Cohort 5
In Cohort 5, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo twice per day for 5 days.
干预措施: Placebo (Drug)
Ph1b Expansion
In the Ph1b expansion cohort, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once or twice per day for 5 days. This cohort may be opened per Sponsor's discretion based on initial safety and activity.
干预措施: IGM-6268 (Drug)
Ph1b Expansion
In the Ph1b expansion cohort, mild-moderate Covid patients will be randomized to receive one intranasal and intraoral administration of 7.5 mg of IGM 6268 or placebo once or twice per day for 5 days. This cohort may be opened per Sponsor's discretion based on initial safety and activity.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety & tolerability of IGM-6268 by assessing the number, severity, and type of adverse events per CTCAE 5.0
时间窗: Through 60 days following receipt of final dose
次要结局
- Concentration of IGM-6268 in serum(Predose through Day 6 (healthy volunteers) or Day 5 (mild-moderate COVID patients))
- Incidence of anti-IGM-6268 antibodies in serum(Prior to dosing and at Day 28 following receipt of initial dose)