Status:
UNKNOWN
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral Drug
Lead Sponsor:
Caregen Co. Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study Design This is a phase 1, randomized, Vehicle-controlled, double-blinded study to assess the safety of Caregen Intranasal CG-SpikeDown in healthy subjects. All randomized subjects will receive ...
Detailed Description
This is a phase 1, Randomized, Double-blinded, Vehicle-controlled, Single and Multi-Dose, Dose Escalation Study, which will assess the safety of the Caregen CG-SpikeDown drug self-administered intrana...
Eligibility Criteria
Inclusion
- Stage I Inclusion Criteria
- Age ≥ 18 years in healthy condition
- Able and willing to sign ICF
- Stage I Exclusion Criteria
- Known hypersensitivity to any of the DP ingredients.
- Pregnant or lactating woman.
- Participation in another clinical study within 4 weeks from screening
- Patient has a positive test for HBV, HCV or HIV
- Subjects diagnosed with allergic rhinitis and/or deviated septum and/or sinusitis.
- Any medical condition that in the investigator's opinion will jeopardize the patient's ability to follow the protocol.
- Stage II Inclusion Criteria
- Age ≥ 18 years
- Laboratory confirmed SARS-CoV2 Infection by nasopharyngeal RT-PCR.
- COVID-19 symptoms within 3 days of symptoms onset
- Patients diagnosed with COVID-19 that are not hospitalized (classified on the NIAID 8-point ordinal scale as 1 or 2).
- Stage II Exclusion Criteria
- Patients who may require hospitalization during the study
- Immunocompromised COVID-19 patients.
- Known hypersensitivity to any of the DP ingredients.
- Patient has a positive test for HBV, HCV or HIV
- Pregnant or lactating woman.
- Participation in another clinical study within 4 weeks from screening
- Subjects diagnosed with allergic rhinitis and/or deviated septum and/or sinusitis.
- Any medical condition that in the investigator's opinion will jeopardize the patient's ability to follow the protocol.
Exclusion
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05234320
Start Date
October 1 2022
End Date
January 1 2023
Last Update
September 22 2022
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