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ACTIVE NOT RECRUITING
NCT07095049
PHASE1

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

Sponsor: Interna Therapeutics Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase1, Randomized, Double-Blind, Placebo-Controlled Study of Single, Twice Daily (BID), and Repeated Dosing of Ascending Doses, to Evaluate Safety, Tolerability, and Systemic Exposure of Intranasal Administration Apo-Si-K170A-C76 in Healthy Subjects.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-09-04

Completion Date

2025-08-30

Last Updated

2025-07-31

Healthy Volunteers

Yes

Interventions

DRUG

Apo-Si-K170A-C76

Apo-Si-K170A-C76 is an small interfering RNA (siRNA) against SARS-CoV-2

DRUG

Placebo

5% glucose, 0.5% benzyl alcohol in RNase free water

Locations (1)

HCRC Ein Karem

Jerusalem, Israel