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

NCT04893512 | Completed Phase 1 DMC

• 1 other identifier: CoV2-OGEN1-101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of 2 dose vaccination schedule of orally administered CoV2-OGEN1 In healthy subjects

Conditions

SARS-CoV-2 (COVID-19)

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of 2-dose vaccination schedule of orally administered CoV2-OGEN1 by following local and systemic adverse events

  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.

  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

Secondary Outcomes (6)

• To evaluate geometric mean fold rise (GMFR)

  From baseline on day 43

• To evaluate geometric mean fold rise (GMFR)

  From baseline on day 43

• To evaluate geometric mean fold rise (GMFR)

  From baseline on day 43

• To evaluate geometric mean titer (GMT)

  On day 43

• To evaluate geometric mean titer (GMT)

  On day 43

Study Arms (1)

Orally administered CoV2-OGEN1- 2 dose schedule

EXPERIMENTAL

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

Interventions

Orally Suspension of CoV2-OGEN1 DRUG

CoV2-OGEN1 will be supplied as a 10mL oral suspension in a plastic bottle containing 50-200 mcg of formulated drug

Orally administered CoV2-OGEN1- 2 dose schedule

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must fulfil all of the following criteria to be eligible for the study:
• Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol and be available for all study visits.
• Must agree to collection of nasal wash, oral rinse, and venous blood per protocol and agree to have samples stored for secondary research.
• Male or non-pregnant female, \>/= to 18 years and \</= 56 years of age at time of enrollment.
• Body Mass Index (BMI) 18-35 kg/m\^2 at screening.
• Women of childbearing potential must agree to use or have practiced true abstinence or use at least one acceptable primary form of contraception. Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement).
• Male subjects of childbearing potential: use of condoms to ensure effective contraception with a female partner of childbearing potential from first vaccination until 90 days after the last vaccination.
• Male subjects agree to refrain from sperm donation from the time of first vaccination until 90 days after the last vaccination.
• In good health as determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of subjects. (Note: Chronic medical diagnoses/conditions/medications should be stable for the last 60 days (no hospitalizations, emergency room (ER), or urgent care for condition or need for supplemental oxygen)).
• Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
• Pulse no greater than 100 beats per minute.
• Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
• Clinical screening laboratory evaluations (Basic Metabolic Panel, White blood cell (WBC), Hemoglobin (Hgb), Hematocrit (HCT), RBC count, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), platelets (PLTs), Total Neutrophils - Absolute (NEUT#), Eosinophils - Absolute (EO#), Monocytes - Absolute (MONO#), Basophils - Absolute (BASO#), Lymphocytes - Absolute (LYMPH#), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin (T. Bili), Lipase, prothrombin time (PT), and partial thromboplastin time (PTT)) are within the acceptable normal reference ranges of the clinical laboratory. Subjects with out of range values may be included if the clinical laboratory or PI deem the out of range value to be clinically insignificant.
• The subject must agree to refrain from donating blood or plasma during the study (outside of this study).

You may not qualify if:

• Participants will be excluded from participation in the study if any of the following criteria are met at screening:
• Positive pregnancy test either at screening or just prior to the first vaccine administration.
• Participants who is breastfeeding or planning on breastfeeding from the time of the first vaccination through 60 days after the last vaccination.
• Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
• Acute or chronic gastrointestinal conditions such as Crohn's, Ulcerative Colitis, gastritis, proctitis, IBS, or any other inflammatory bowel disease.
• Currently taking Histamine-2 (H2) Blocker, Proton Pump Inhibitor (PPI), Promotility Agent, or any chronic antacids.
• Presence of self-reported or medically documented significant medical or psychiatric condition(s).
• Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), uncontrolled hypertension, history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia.
• Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease).
• Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
• Active autoimmune disease or any history of autoimmune disease determined by hx or lab/physical examination.
• Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
• T2DM
• Asthma
• Respiratory conditions (including emphysema or COPD)

Sponsors & Collaborators

• Syneos Health: lead
• US Specialty Formulations, LLC: collaborator

Study Sites (1)

Auckland Clinical Studies Ltd (NZCR OpCo Limited)

Grafton, Auckland, 1010, New Zealand

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: June 30, 2021
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: April 20, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)