SARS-CoV-2Phase 1CORVax12NCT04627675
CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2)
A Phase 1 study testing CORVax, IL-12 plasmid and Cliniporator in people with SARS-CoV-2, run by Providence Health & Services at 1 site in United States.
Trial summary
This is a Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- CORVax, IL-12 plasmid and Cliniporator
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2020to 28 Dec 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult volunteers ages 18 years and above, who are able to provide written informed consent and willing to allow storage and future use of samples for SARS-CoV-2 related research.
- Women of childbearing potential (WOCBP) must have negative serum or urine pregnancy on each day of vaccine administration.
- Males and women of childbearing potential must agree to take appropriate precautions to avoid pregnancy during treatment and through 180 days after last dose of IP.
Who cannot join
- Current or previous SARS-CoV-2 infection or receipt of an experimental treatment for prevention of SARS-CoV-2.
- Administration of any vaccine within 4 weeks of first dose.
- Any laboratory abnormalities at baseline greater than Grade 1 per the "FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical
- Any history of cardiac arrhythmia.
- Any history of epilepsy or seizure within the last five years.
- Use of immunosuppressive medication within 14 days before the first dose of study drug.
Show all 25Show fewer
- Anticipated treatment with TNF-α inhibitors (e.g., infliximab, adalimumab, or etanercept).
- Pregnancy or breastfeeding.
- Body mass index of 35 kg/m2 or more.
- Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose.
- Chronic liver disease or cirrhosis.
- Previous major surgery or any radiation therapy within 4 weeks of group assignment.
- Any pre-excitation syndromes (e.g., Wolff- Parkinson-White syndrome).
- Metal implants within 20cm of the planned site(s) of injection; presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection; tattoos covering the injection site area.
- Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator.
- History of allogeneic organ transplantation.
- History of primary immunodeficiency.
- Known HIV, hepatitis B virus, or hepatitis C virus infection. Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- Uncontrolled intercurrent illness, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.
- Comorbidities, controlled or otherwise, associated with higher risk for severe COVID-19 illness - because our understanding of the pathogenesis of SARS-CoV-2 continues to evolve, this will be based on most current information available at time of screening regarding risk factors for severe disease, using resources such as those described on the Centers for Disease Control website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-higher-risk.html
- Subjects at high-risk for SARS-CoV-2 exposure per investigator, including healthcare workers, first responders, and individuals with known exposure to individuals infected with SARS-CoV-2.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
- History of autoimmune or inflammatory disorders including but not limited to inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, (see Appendix 2).
- Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.
- Investigator discretion relating to any condition which might interfere with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: CORVax12 - a Phase I Trial of SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine (CORVax) +/- pIL-12 (Tavokinogene Telseplasmid) in Healthy Volunteers, With Immunodynamic Biomarker Monitoring of Coordinated Cellular/Humoral Response
This is a Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid.
Read the detailed description
This is a Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid), given as prime \& boost doses, four weeks apart, in healthy volunteers, divided into age groups of 18-50 versus > 50 years old. IL-12p70 plasmid DNA electroporation (tavokinogene telseplasmid) has been extensively studied in over 209 subjects across 11 trials including later stage human cancer trials with more than 1000 administrations. The IGEA CLINIPORATOR® system is approved for clinical use in Europe, but remains investigational in this study.
One participant will initially be enrolled to each of four cohorts and monitored over a 7-day DLT window:
1A. Age 18-50; CORVax.
- B. Age 18-50; CORVax + pIL-12.
- A. Age > 50; CORVax.
2B. Age > 50; CORVax + pIL-12.
If after 7 days, no DLT are observed, the cohort may proceed to enroll a second participant. If after monitoring the second participant for 7 days, no DLT are observed, the cohort may proceed to enroll a third participant. If after monitoring the third participant for 7 days, no DLT are observed, the cohort may proceed to enroll six additional participants, for a total of nine participants per cohort using a (1+1+1, +6) design.
- Conditions
- SARS-CoV-2
- Being tested
- CORVax, IL-12 plasmid, Cliniporator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORVaxDrug
DNA-encodable coronaviral vaccine
IL-12 plasmidDrug
cytokine
CliniporatorDevice
electroporation system
| Study group | Role | What they receive |
|---|---|---|
| 1A: Age 18-50; CORVax | Experimental | Healthy volunteers age 18-50 will receive CORVax Receives: Drug: CORVax; Device: Cliniporator |
| 1B: Age 18-50; CORVax + pIL-12 | Experimental | Healthy volunteers age 18-50 will receive CORVax + pIL-12 Receives: Drug: CORVax; Drug: IL-12 plasmid; Device: Cliniporator |
| 2A: Age > 50; CORVax | Experimental | Healthy volunteers age > 50 will receive CORVax Receives: Drug: CORVax; Device: Cliniporator |
| 2B: Age > 50; CORVax + pIL-12 | Experimental | Healthy volunteers age > 50 will receive CORVax + pIL-12 Receives: Drug: CORVax; Drug: IL-12 plasmid; Device: Cliniporator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events Occurring on Day 1
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 1
Number of Participants With Adverse Events Occurring on Day 2
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 2
Number of Participants With Adverse Events Occurring on Day 3
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 3
Number of Participants With Adverse Events Occurring on Day 15
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 15
Number of Participants With Adverse Events Occurring on Day 30
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 30
Number of Participants With Adverse Events Occurring on Day 31
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 31
Number of Participants With Adverse Events Occurring on Day 32
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 32
Number of Participants With Adverse Events Occurring on Day 45
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 45
Number of Participants With Adverse Events Occurring on Day 60
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 60
Number of Participants With Adverse Events Occurring on Day 90
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Measured: Day 90
Medically Attended Adverse Events (MAAEs)
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs).
Measured: Day 30
Medically Attended Adverse Events (MAAEs)
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Measured: Day 60
Medically Attended Adverse Events (MAAEs)
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Measured: Day 90
Medically Attended Adverse Events (MAAEs)
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Measured: Month 6
Medically Attended Adverse Events (MAAEs)
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Measured: Month 12
Medically Attended Adverse Events (MAAEs)
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start30 Dec 2020
- Primary completion19 Sep 2022
- Study completion28 Dec 2022
Why it stopped: Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- OncoSec Medical Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627675
- Sponsor's protocol ID
- 2020000320 CORVax12
- Acronym
- CORVax12
- Status last verified
- Oct 2024
- First submitted
- 6 Nov 2020
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORVax12 - a Phase I Trial of SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine (CORVax) +/- pIL-12 (Tavokinogene Telseplasmid) in Healthy Volunteers, With Immunodynamic Biomarker Monitoring of Coordinated Cellular/Humoral Response
- ClinicalTrials.gov ID
- NCT04627675
- Acronym / sponsor ID
- CORVax12 / 2020000320 CORVax12
- Conditions
- SARS-CoV-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- OncoSec Medical Incorporated
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Posted 26 Oct 2024
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 Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid.
Detailed description
This is a Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid), given as prime \& boost doses, four weeks apart, in healthy volunteers, divided into age groups of 18-50 versus > 50 years old. IL-12p70 plasmid DNA electroporation (tavokinogene telseplasmid) has been extensively studied in over 209 subjects across 11 trials including later stage human cancer trials with more than 1000 administrations. The IGEA CLINIPORATOR® system is approved for clinical use in Europe, but remains investigational in this study.
One participant will initially be enrolled to each of four cohorts and monitored over a 7-day DLT window:
1A. Age 18-50; CORVax.
- B. Age 18-50; CORVax + pIL-12.
- A. Age > 50; CORVax.
2B. Age > 50; CORVax + pIL-12.
If after 7 days, no DLT are observed, the cohort may proceed to enroll a second participant. If after monitoring the second participant for 7 days, no DLT are observed, the cohort may proceed to enroll a third participant. If after monitoring the third participant for 7 days, no DLT are observed, the cohort may proceed to enroll six additional participants, for a total of nine participants per cohort using a (1+1+1, +6) design.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1A: Age 18-50; CORVax | Experimental | Drug: CORVax, Device: CliniporatorHealthy volunteers age 18-50 will receive CORVax |
| 1B: Age 18-50; CORVax + pIL-12 | Experimental | Drug: CORVax, Drug: IL-12 plasmid, Device: CliniporatorHealthy volunteers age 18-50 will receive CORVax + pIL-12 |
| 2A: Age > 50; CORVax | Experimental | Drug: CORVax, Device: CliniporatorHealthy volunteers age > 50 will receive CORVax |
| 2B: Age > 50; CORVax + pIL-12 | Experimental | Drug: CORVax, Drug: IL-12 plasmid, Device: CliniporatorHealthy volunteers age > 50 will receive CORVax + pIL-12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult volunteers ages 18 years and above, who are able to provide written informed consent and willing to allow storage and future use of samples for SARS-CoV-2 related research.
- Women of childbearing potential (WOCBP) must have negative serum or urine pregnancy on each day of vaccine administration.
- Males and women of childbearing potential must agree to take appropriate precautions to avoid pregnancy during treatment and through 180 days after last dose of IP.
Key exclusion criteria (25 listed)
- Current or previous SARS-CoV-2 infection or receipt of an experimental treatment for prevention of SARS-CoV-2.
- Administration of any vaccine within 4 weeks of first dose.
- Any laboratory abnormalities at baseline greater than Grade 1 per the "FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical
- Any history of cardiac arrhythmia.
- Any history of epilepsy or seizure within the last five years.
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 |
|---|---|---|
| CORVaxDNA-encodable coronaviral vaccine | Drug | 1A: Age 18-50; CORVax, 1B: Age 18-50; CORVax + pIL-12, 2A: Age > 50; CORVax, 2B: Age > 50; CORVax + pIL-12 |
| IL-12 plasmidcytokine | Drug | 1B: Age 18-50; CORVax + pIL-12, 2B: Age > 50; CORVax + pIL-12 |
| Cliniporatorelectroporation system | Device | 1A: Age 18-50; CORVax, 1B: Age 18-50; CORVax + pIL-12, 2A: Age > 50; CORVax, 2B: Age > 50; CORVax + pIL-12 |
Primary outcome
Number of Participants With Adverse Events Occurring on Day 1
Time frame: Day 1
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 2
Time frame: Day 2
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 3
Time frame: Day 3
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 15
Time frame: Day 15
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 30
Time frame: Day 30
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 31
Time frame: Day 31
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 32
Time frame: Day 32
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 45
Time frame: Day 45
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 60
Time frame: Day 60
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Number of Participants With Adverse Events Occurring on Day 90
Time frame: Day 90
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.)
Medically Attended Adverse Events (MAAEs)
Time frame: Day 30
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs).
Medically Attended Adverse Events (MAAEs)
Time frame: Day 60
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Medically Attended Adverse Events (MAAEs)
Time frame: Day 90
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Medically Attended Adverse Events (MAAEs)
Time frame: Month 6
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Medically Attended Adverse Events (MAAEs)
Time frame: Month 12
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Medically Attended Adverse Events (MAAEs)
Time frame: Month 18
Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CORVax, IL-12 plasmid and Cliniporator in people with SARS-CoV-2, run by Providence Health & Services at 1 site in United States.
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 25 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: stopped early, as of the sponsor's last update on 26 Oct 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Adverse Events Occurring on Day 1 (time frame: Day 1). The study lists 16 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 26 Oct 2024.