Clinical Trial

Safety, Tolerability, and Systemic Exposure of Apo-Si- K170A-C76 in Healthy Volunteers

Study acronym: BID
Active, Not Recruiting Phase 1
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Summary
The goal of this First in Human Phase 1 clinical trial is to to assess the safety, tolerability, and systemic exposure of single, twice daily (BID) doses and repeated BID doses of ascending dosing by intranasal administration of Apo-Si-K170AC76 in healthy adult subjects. The primary objective is to evaluate the safety and tolerability of single, BID, and repeated BID, ascending dosing of Apo-Si-K170A-C76 administered intranasally (IN) in healthy adult subjects. The secondary objective is to evaluate the systemic exposure to Apo-Si-K170A-C76 following intranasal administration in healthy adult subjects under the aforementioned administration regimens. Researchers will compare the active drug Apo-Si-K170A-C76 to placebo control.
Trial Details
NCT Number NCT07095049
Lead Sponsor Interna Therapeutics Ltd.
Conditions SARS-CoV-2 (COVID-19) Infection
Enrollment 56 participants
Start Date 2024-09-04
Primary Completion 2025-07-14 (estimated)
Study Completion 2025-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-31