Covid19Phase 1NCT04839042
A Phase 1, First-In-Human Study of the Investigational COVID-19 Vaccine SC-Ad6-1 in Healthy Volunteers
A Phase 1 study testing SC-Ad6-1 in people with Covid19, run by Moat Biotechnology Corporation at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- SC-Ad6-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Jun 2021to 4 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Covid19
- Being tested
- SC-Ad6-1
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC-Ad6-1Biological
SC-Ad6-1, I.M., single or multiple-dose
SC-Ad6-1Biological
SC-Ad6-1, I.N., single or multiple-dose
SC-Ad6-1Biological
SC-Ad6-1, I.H., single or multiple-dose
| Study group | Role | What they receive |
|---|---|---|
| SC-Ad6-1 Low Dose Intramuscular | Experimental | Low Dose SC-Ad6-1, I.M., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Medium Dose Intramuscular | Experimental | Medium Dose SC-Ad6-1, I.M., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 High Dose #1 Intramuscular | Experimental | High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 High Dose #2 Intramuscular | Experimental | High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Multiple Dose Intramuscular | Experimental | Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 High Dose #3 Intramuscular Booster | Experimental | High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Low Dose Intranasal | Experimental | Low Dose SC-Ad6-1, I.N., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Medium Dose Intranasal | Experimental | Medium Dose SC-Ad6-1, I.N., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 High Dose #1 Intranasal | Experimental | High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 High Dose #2 Intranasal | Experimental | High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Multiple Dose Intranasal | Experimental | Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 High Dose #3 Intranasal Booster | Experimental | High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 High Dose #4 Intranasal Booster | Experimental | High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Low Dose Inhaled | Experimental | Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Medium Dose Inhaled | Experimental | Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Multiple High Dose Intranasal | Experimental | Multiple High Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 29) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Multiple High Dose Inhaled | Experimental | Multiple High Dose SC-Ad6-1, I.H., multiple-dose (Day 1 and Day 29) Receives: Biological: SC-Ad6-1 |
| SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled | Experimental | Multiple High Dose #2 SC-Ad6-1, I.N. or I.H., multiple-dose (Day 1 and Day 29) Receives: Biological: SC-Ad6-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with solicited local and systemic adverse events for 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.
Measured: 7 days following each dose
Incidence and severity of adverse events (AEs), including withdrawals due to safety or tolerability reasons
Measured: Up to 106 days following first dose
Humoral response to SARS-CoV-2 as measured by neutralizing antibodies using wild-type virus assay
Measured: Up to 106 days following first dose
Secondary outcomes (4)
Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA)
Measured: Up to 106 days following first dose
Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA
Measured: Up to 106 days following first dose
Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)
Measured: Up to 106 days following first dose
Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))
Measured: Up to 106 days following first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start28 Jun 2021
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moat Biotechnology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Rother, Ph.D., Study director, Moat Biotechnology Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839042
- Sponsor's protocol ID
- SC-Ad6-1-002
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2021
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04839042
- Acronym / sponsor ID
- SC-Ad6-1-002
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Moat Biotechnology CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| SC-Ad6-1 Low Dose Intramuscular | Experimental | Biological: SC-Ad6-1Low Dose SC-Ad6-1, I.M., single-dose (Day 1) |
| SC-Ad6-1 Medium Dose Intramuscular | Experimental | Biological: SC-Ad6-1Medium Dose SC-Ad6-1, I.M., single-dose (Day 1) |
| SC-Ad6-1 High Dose #1 Intramuscular | Experimental | Biological: SC-Ad6-1High Dose #1 SC-Ad6-1, I.M., single-dose (Day 1) |
| SC-Ad6-1 High Dose #2 Intramuscular | Experimental | Biological: SC-Ad6-1High Dose #2 SC-Ad6-1, I.M., single-dose (Day 1) |
| SC-Ad6-1 Multiple Dose Intramuscular | Experimental | Biological: SC-Ad6-1Multiple Dose SC-Ad6-1, I.M., multiple-dose (Day 1 and Day 22) |
| SC-Ad6-1 High Dose #3 Intramuscular Booster | Experimental | Biological: SC-Ad6-1High Dose #3 SC-Ad6-1, I.M., single-dose booster (Day 1) |
| SC-Ad6-1 Low Dose Intranasal | Experimental | Biological: SC-Ad6-1Low Dose SC-Ad6-1, I.N., single-dose (Day 1) |
| SC-Ad6-1 Medium Dose Intranasal | Experimental | Biological: SC-Ad6-1Medium Dose SC-Ad6-1, I.N., single-dose (Day 1) |
| SC-Ad6-1 High Dose #1 Intranasal | Experimental | Biological: SC-Ad6-1High Dose #1 SC-Ad6-1, I.N., single-dose (Day 1) |
| SC-Ad6-1 High Dose #2 Intranasal | Experimental | Biological: SC-Ad6-1High Dose #2 SC-Ad6-1, I.N., single-dose (Day 1) |
| SC-Ad6-1 Multiple Dose Intranasal | Experimental | Biological: SC-Ad6-1Multiple Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 22) |
| SC-Ad6-1 High Dose #3 Intranasal Booster | Experimental | Biological: SC-Ad6-1High Dose #3 SC-Ad6-1, I.N., single-dose booster (Day 1) |
| SC-Ad6-1 High Dose #4 Intranasal Booster | Experimental | Biological: SC-Ad6-1High Dose #4 SC-Ad6-1, I.N., single-dose booster (Day 1) |
| SC-Ad6-1 Low Dose Inhaled | Experimental | Biological: SC-Ad6-1Low Dose SC-Ad6-1, I.H., single-dose booster (Day 1) |
| SC-Ad6-1 Medium Dose Inhaled | Experimental | Biological: SC-Ad6-1Medium Dose SC-Ad6-1, I.H., single-dose booster (Day 1) |
| SC-Ad6-1 Multiple High Dose Intranasal | Experimental | Biological: SC-Ad6-1Multiple High Dose SC-Ad6-1, I.N., multiple-dose (Day 1 and Day 29) |
| SC-Ad6-1 Multiple High Dose Inhaled | Experimental | Biological: SC-Ad6-1Multiple High Dose SC-Ad6-1, I.H., multiple-dose (Day 1 and Day 29) |
| SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled | Experimental | Biological: SC-Ad6-1Multiple High Dose #2 SC-Ad6-1, I.N. or I.H., multiple-dose (Day 1 and Day 29) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC-Ad6-1SC-Ad6-1, I.M., single or multiple-dose | Biological | SC-Ad6-1 High Dose #1 Intramuscular, SC-Ad6-1 High Dose #2 Intramuscular, SC-Ad6-1 High Dose #3 Intramuscular Booster, SC-Ad6-1 Low Dose Intramuscular, SC-Ad6-1 Medium Dose Intramuscular, SC-Ad6-1 Multiple Dose Intramuscular |
| SC-Ad6-1SC-Ad6-1, I.N., single or multiple-dose | Biological | SC-Ad6-1 High Dose #1 Intranasal, SC-Ad6-1 High Dose #2 Intranasal, SC-Ad6-1 High Dose #3 Intranasal Booster, SC-Ad6-1 High Dose #4 Intranasal Booster, SC-Ad6-1 Low Dose Intranasal, SC-Ad6-1 Medium Dose Intranasal, SC-Ad6-1 Multiple Dose Intranasal, SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled, SC-Ad6-1 Multiple High Dose Intranasal |
| SC-Ad6-1SC-Ad6-1, I.H., single or multiple-dose | Biological | SC-Ad6-1 Low Dose Inhaled, SC-Ad6-1 Medium Dose Inhaled, SC-Ad6-1 Multiple High Dose #2 Intranasal or Inhaled, SC-Ad6-1 Multiple High Dose Inhaled |
Primary outcome
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
4 secondary outcomes
Humoral response to SARS-CoV-2 as measured by serum IgG and IgA antibodies to the SARS-CoV-2 spike protein (ELISA)
Time frame: Up to 106 days following first dose
Humoral response to SARS-CoV-2 as measured by mucosal IgA antibodies to the SARS-CoV-2 spike protein (ELISA) and total mucosal IgA
Time frame: Up to 106 days following first dose
Measurement of cytokine-producing T cells specific for the SARS-CoV-2 spike protein (ELISpot)
Time frame: Up to 106 days following first dose
Measurement of adenovirus 6 (Ad6) neutralizing antibodies (anti-drug antibodies (ADA))
Time frame: Up to 106 days following first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Rother, Ph.D. study director
Moat Biotechnology Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC-Ad6-1 in people with Covid19, run by Moat Biotechnology Corporation at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with solicited local and systemic adverse events for 7 days Following Each Dose (time frame: 7 days following each dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.