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

NCT05753878 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Huahui Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05753878 on ClinicalTrials.gov