drugset / Trial / NCT05753878

A Study to Evaluate the Safety and Pharmacokinetics of HH-120 Nasal Spray in Healthy Volunteers

NCT05753878

Phase 1 Completed 62 enrolled Huahui Health
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a clinical study evaluating the safety, tolerability, pharmacokinetic (PK) characteristics and immunogenicity of HH-120 nasal spray in healthy subjects. This study is divided into two parts: Part A is of open-label design and mainly aims to assess the local distribution and PK in nasal cavity of HH-120 nasal spray, subjects from 10 cohorts are sequentially enrolled to perform either nasal endoscopic examination or nasal/ nasopharyngeal samples collection at different time points post administration. Part B mainly aims to assess the safety, systematic pharmacokinetic and immunogenicity after multiple dosing of HH-120 nasal spray, subjects are randomly assigned (3:1) to HH-120 and placebo groups.

Timeline

Start
2022-11-08
Primary completion
2023-01-09
Completion
2023-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject HH-120 Protein / enzyme biologic Intranasal
Background Methylene Blue Diagnostic / imaging agent 1 mg/ml

Indications