A Phase 1, First-In-Human, Open-label, Single Ascending Dose and Multidose Study to Assess the Safety, Reactogenicity, and Immunogenicity of the Adenovirus Vector SARS-CoV-2 Investigational Product SC-Ad6-1 Given Via Intramuscular, Intranasal or Inhaled Administration in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- SC-Ad6-1
- Conditions
- Covid19
- Sponsor
- Moat Biotechnology Corporation
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
This is a single-centre, open-label, first-in-human, single ascending dose and multiple dose study to assess the safety, reactogenicity, and immunogenicity of the SC-Ad6-1 investigational product when administered via the intramuscular (IM), intranasal (IN) or inhaled (IH) route in healthy volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult males and females, 18 to 60 years of age (inclusive)
- •Body mass index ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight ≥ 50 kg at screening
- •Must have been fully vaccinated against COVID-19 and received last dose not less than 3 months prior to Day 1 (High Dose #3 I.M. and I.N. booster arms only), not less than 5 months prior to Day 1 (High Dose #4 I.N. booster arm only) and not less than 12 months prior to Day 1 (I.H. booster arms and I.N or I.H. multiple dose booster arms only)
Exclusion Criteria
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease
- •History of chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent (≤14 days prior to Screening) or ongoing respiratory tract infection
- •History of thrombosis (e.g., deep vein thrombosis, pulmonary embolism, etc.), any coagulation dysregulation disorder, or a history of thrombosis noted in immediate family members
- •History of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
- •Known previous infection with SARS-CoV-2 or presence of antibodies against SARS-CoV-2 or a positive SARS-CoV-2 PCR test (non-booster arms only)
- •Any history of malignant disease ≤5 years prior to registration
- •History of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
Arms & Interventions
SC-Ad6-1 Low Dose Intramuscular
Low Dose SC-Ad6-1, I.M., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Medium Dose Intramuscular
Medium Dose SC-Ad6-1, I.M., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 High Dose #1 Intramuscular
High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 High Dose #2 Intramuscular
High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Multiple Dose Intramuscular
Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22)
Intervention: SC-Ad6-1
SC-Ad6-1 High Dose #3 Intramuscular Booster
High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Low Dose Intranasal
Low Dose SC-Ad6-1, I.N., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Medium Dose Intranasal
Medium Dose SC-Ad6-1, I.N., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 High Dose #1 Intranasal
High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 High Dose #2 Intranasal
High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Multiple Dose Intranasal
Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22)
Intervention: SC-Ad6-1
SC-Ad6-1 High Dose #3 Intranasal Booster
High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 High Dose #4 Intranasal Booster
High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Low Dose Inhaled
Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Medium Dose Inhaled
Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1)
Intervention: SC-Ad6-1
SC-Ad6-1 Multiple High Dose Intranasal
Multiple High Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 29)
Intervention: SC-Ad6-1
SC-Ad6-1 Multiple High Dose Inhaled
Multiple High Dose SC-Ad6-1, I.H., multiple-dose (Day 1 and Day 29)
Intervention: SC-Ad6-1
SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled
Multiple High Dose #2 SC-Ad6-1, I.N. or I.H., multiple-dose (Day 1 and Day 29)
Intervention: SC-Ad6-1
Outcomes
Primary Outcomes
Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose
Time Frame: 7 days following each dose
Solicited local adverse events are defined as pain, redness and swelling at the site of dose administration for the intramuscular arms, are defined as stuffy nose, runny nose, nasal discomfort, loss of smell, sore or scratchy throat for the intranasal arms and are defined as stuffy nose, runny nose, dry mouth, mouth sores, sore or scratchy throat and cough for the inhalation arms. Solicited systemic adverse events for all routes of administration are defined as fever, headache, muscle pain, joint pain, fatigue, nausea or vomiting, and chills.
Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons
Time Frame: Up to 106 days following first dose
Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay
Time Frame: Up to 106 days following first dose
Secondary Outcomes
- Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA(Up to 106 days following first dose)
- Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)(Up to 106 days following first dose)
- Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))(Up to 106 days following first dose)
- Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA)(Up to 106 days following first dose)