First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects
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ClinicalTrials.gov Identifier: NCT04893512 |
Recruitment Status :
Completed
First Posted : May 19, 2021
Last Update Posted : April 20, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | May 14, 2021 | ||||
First Posted Date ICMJE | May 19, 2021 | ||||
Last Update Posted Date | April 20, 2023 | ||||
Actual Study Start Date ICMJE | June 30, 2021 | ||||
Actual Primary Completion Date | November 11, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To evaluate the safety of 2-dose vaccination schedule of orally administered CoV2-OGEN1 by following local and systemic adverse events [ Time Frame: Non serious AE are to assessed for 21-28 days after each study vaccination while serious AE are to be followed for atleast 6 months after completion of all study vaccinations ] Solicited local and systemic adverse events (may include Gi Disturbance)-Potential systemic events may include fever, fatigue, headache and chills following vaccination. Potential local events may include nausea, vomiting, diarrhea, and gastrointestinal discomfort following vaccination.
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Original Primary Outcome Measures ICMJE |
To evaluate the safety of 2-dose vaccination schedule of orally administered CoV2-OGEN1 [ Time Frame: Non serious AE are to assessed for atleast 28 days after each study vaccination while serious AE are to be folowed for atleast 6 months after completion of all study vaccinations ] Solicited local and systemic adverse events (may include Gi Disturance)-Potential systemic events may include fever, fatigue, headache and chills following vaccination. Potential local events may include nausea, vomiting, diarrhea, and gastrointestinal discomfort following vaccination.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects | ||||
Official Title ICMJE | First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects | ||||
Brief Summary | To evaluate the safety of 2 dose vaccination schedule of orally administered CoV2-OGEN1 In healthy subjects | ||||
Detailed Description | The study will be conducted at 1 site in NZ. Patients who sign an Informed Consent and meet all eligibility criteria will be administered oral doses of 50mcg, 100mcg and 200mcg CoV2-OGEN1 on Day 1 and Day 15 during Cohort 1-3 respectively . Follow up visit in all the 3 cohorts will be performed at 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months, and 12 months. One sentinel subject will be dosed at the start of each cohort and will be monitored for 24 hours post administration before the remainder of the cohort can be recruited. Each cohort will include one sentinel subject. Dose escalation will be done after assessing all adverse events and their relatedness in atleast 9 participants out of 15 receiving Cov2-OGEN1 who have completed their week 6 FU visit. In case three (3) or more participants receiving CoV2-OGEN1 withdraw before Visit 6 (Week 4) follow up visit, the dose escalation safety assessment will be made by assessing all Adverse Events and their relatedness status in all participants receiving CoV2-OGEN1 of the current Cohort. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | SARS-CoV-2 (COVID-19) | ||||
Intervention ICMJE | Drug: Orally Suspension of CoV2-OGEN1
CoV2-OGEN1 will be supplied as a 10mL oral suspension in a plastic bottle containing 50-200 mcg of formulated drug
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Study Arms ICMJE | Experimental: Orally administered CoV2-OGEN1- 2 dose schedule
50mcg,100mcg and 200mcg will be tested as single oral dose on day 1 and day 15. The dose will be in the form of oral suspension.
Intervention: Drug: Orally Suspension of CoV2-OGEN1
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
45 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 11, 2022 | ||||
Actual Primary Completion Date | November 11, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Participants must fulfil all of the following criteria to be eligible for the study:
Exclusion criteria Participants will be excluded from participation in the study if any of the following criteria are met at screening:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 56 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | New Zealand | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04893512 | ||||
Other Study ID Numbers ICMJE | CoV2-OGEN1-101 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Syneos Health | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Syneos Health | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | US Specialty Formulations, LLC | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Syneos Health | ||||
Verification Date | January 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |