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NOT YET RECRUITING
NCT07898306
PHASE1

Nasal Residency of HEX17

Sponsor: Pneumagen Ltd, a subsidiary of NorthLinks Bio

View on ClinicalTrials.gov

Summary

This Phase 1 study will evaluate HEX17, an investigational antiviral nasal spray, in healthy adult volunteers. The study has two parts. Part A will validate a laboratory method called fluorescence activated cell sorting (FACS) to detect HEX17 bound to nasal epithelial cells after a single intranasal dose. Part B will investigate how long HEX17 remains present in nasal epithelial cells following five different dosing regimens. The study will also assess the safety and tolerability of HEX17 following intranasal administration in healthy adult participants.

Official title: A Two-part, Single Blind, Parallel Group, Phase 1 Study to Validate the Use of Fluorescence Activated Cell Sorting (FACS) Assay to Detect HEX17 Bound to Nasal Epithelial Cells (Part A) and to Investigate the Nasal Residence of HEX17 Using Five Dosing Regimens in Healthy Adult Participants (Part B).

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2026-10-20

Completion Date

2027-01-25

Last Updated

2026-10-27

Healthy Volunteers

Yes

Interventions

DRUG

HEX17

HEX17 liquid for intranasal spray administration. Participants receive a 2.8 mg dose administered as one actuation into each nostril. In Part A participants receive a single dose. In Part B participants receive HEX17 according to one of five dosing regimens: single dose, daily, twice weekly, weekly, or every two weeks.

DRUG

Placebo

Matching placebo liquid for intranasal spray administration used as a comparator control.

Locations (1)

Medicines Evaluation Unit, an IQVIA Business

Manchester, Wythenshawe, United Kingdom