Overview

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:
Participant gender:
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
Details
Lead Sponsor:
Caregen Co. Ltd.