NCT04893512

First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS-CoV-2 (COVID-19)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2021-05-19
• Last updated: 2023-04-20

Locations

1 site across 1 country: New Zealand