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

NCT07095049 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-07-31

No results posted yet for this study

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.

Conditions

  • SARS-CoV-2 (COVID-19) Infection

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

Sponsors & Collaborators

  • Interna Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Hagit Grimberg, PhD · Interna Therapeutics Ltd.

  • Yoseph Caraco, MD · HCRC Ein Karem, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2025-07-14
Completion
2025-08-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07095049 on ClinicalTrials.gov