NCT05753878

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

A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Immunogenicity of HH-120 Nasal Spray in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Huahui Health · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	HH-120 nasal spray, PartA cohort 1	A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection.
DRUG	HH-120 nasal spray, Part A cohort 2-7	A single dose of HH-120 nasal spray.
DRUG	HH-120 nasal spray, Part A cohort 8-9	Two doses of HH-120 nasal spray.
DRUG	HH-120 nasal spray, Part B	HH-120 nasal spray, 10 times daily for 7 consecutive days.
OTHER	Placebo nasal spray, Part B	Placebo nasal spray, 10 times daily for 7 consecutive days.

Timeline

• Start date: 2022-11-08
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2023-03-03
• Last updated: 2023-09-28

Locations

1 site across 1 country: China