First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT04893512|
Recruitment Status : Active, not recruiting
First Posted : May 19, 2021
Last Update Posted : January 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 (COVID-19)||Drug: Orally Suspension of CoV2-OGEN1||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects|
|Actual Study Start Date :||June 30, 2021|
|Actual Primary Completion Date :||December 9, 2021|
|Estimated Study Completion Date :||December 9, 2022|
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.
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
- 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.
- To evaluate geometric mean fold rise (GMFR) [ Time Frame: From baseline on day 43 ]In mucosal IgA titer
- To evaluate geometric mean fold rise (GMFR) [ Time Frame: From baseline on day 43 ]In serum IgG titer
- To evaluate geometric mean fold rise (GMFR) [ Time Frame: From baseline on day 43 ]In serum IgA titer
- To evaluate geometric mean titer (GMT) [ Time Frame: On day 43 ]Of mucosal antibody
- To evaluate geometric mean titer (GMT) [ Time Frame: On day 43 ]Of serum antibody
- To evaluate percentage of subjects [ Time Frame: On day 43 ]Seroconverted
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893512
|Auckland Clinical Studies Ltd (NZCR OpCo Limited)|
|Grafton, Auckland, New Zealand, 1010|