Study in Healthy Subjects and Symptomatic Covid-19 Positive Patients to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of the Novel Self-administered Intranasal CG- SpikeDown Antiviral Drug

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1/2, randomized, placebo-controlled, double-blinded study, to assess safety of Caregen Intranasal CG-SpikeDown in healthy subjects and and safety and efficacy (via viral load profile) in non-hospitalized symptomatic COVID-19 patients within 3 days of symptoms onset.

All randomized COVID-19 patients will receive active drug or placebo in addition to standard of care treatment. Patients randomized to the DP active treatment will receive CG-SpikeDown intranasally once daily for seven days at either low (25 mg) or planned (50 mg) dose. The treatment period in this study, during both study stages, is 7 days.

The study will be divided into 2 stages:

Stage I will be conducted on 10 healthy subjects. This stage's purpose is to In Stage II will include 60 symptomatic non-hospitalized COVID-19 patients and will be conducted at patients' homes during their self-isolation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Caregen Co. Ltd.

Criteria

Stage I Inclusion Criteria

1. Age ≥ 18 years in healthy condition

2. Able and willing to sign ICF

Stage I Exclusion Criteria:

1. Hypersensitivity to any of the DP ingredients.

2. Pregnant or lactating women.

3. Participation in another clinical study within 4 weeks from screening

4. Any medical condition that in the investigator's opinion will jeopardize the patient's ability to follow the protocol.

Stage II Inclusion Criteria

1. Age ≥ 18 years.

2. Laboratory confirmed SARS-CoV2 Infection by nasopharyngeal RT-PCR.

3. COVID-19 symptoms within 3 days of symptoms onset.

4. Patients diagnosed with COVID-19 that are not hospitalized.

5. Able and willing to sign ICF.

Stage II Exclusion Criteria

1. Patients who may require hospitalization during the study

2. Hypersensitivity to any of the DP ingredients.

3. Pregnant or lactating women.

4. Participation in another clinical study within 4 weeks from screening

5. Any medical condition that in the investigator's opinion will jeopardize the patient's ability to follow the protocol.