Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers of the Novel Self-Administered Intranasal CG- SpikeDown Antiviral Drug

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 an active drug or Vehicle. Subjects randomized to the DP(Drug product) active treatment will receive CG- SpikeDown intranasally once daily for one or seven days at either a low (25 mg) or planned (50 mg) dose. Subject recruitment will be conducted via study advertisement on social media, and subjects will be adequately compensated. The subjects will arrive each day at the clinic to receive the treatment and will be hospitalized for safety monitoring for the first 24 hours post-DP or vehicle administration.

Timeline

Start

2022-10

Primary completion

2023-01

Completion

2023-01

Outcome

Met primary endpoint

release “CG-SpikeDown의 안전성과 약동학적 특성을 평가하였으며, 임상 1상의 주요 평가 지표들을 충족하여” caregen.co.kr ↗

Drugs

Indications

No indication recorded.