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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
62
A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection.
A single dose of HH-120 nasal spray.
Two doses of HH-120 nasal spray.
HH-120 nasal spray, 10 times daily for 7 consecutive days.
Placebo nasal spray, 10 times daily for 7 consecutive days.
Beijing TongRen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The distribution of HH-120 in the nasal cavity at different time points after single dose of HH-120 nasal spray.(Part A: cohort 1)
Time frame: From baseline to the end of the 7-day follow-up.
Local drug concentration of nasal and nasopharyngeal swab samples before and at different time points after dosing of HH-120 nasal spray.(Part A: cohort 2-9)
Time frame: From baseline to the end of the 7-day follow-up.
The incidence and severity of adverse events and the serious adverse events.(Part B)
Time frame: From baseline to the end of the 29-day follow-up.
The incidence and severity of adverse events and the serious adverse events.(Part A)
Time frame: From baseline to the end of the 7-day follow-up.
Drug concentration of nasopharyngeal swab samples before and after multiple dosing of HH-120 nasal spray.(Part B)
Time frame: From baseline to the end of the 29-day follow-up.
Maximum plasma concentration (Cmax).(Part B)
Time frame: From baseline to the end of the 29-day follow-up.
Peak time (Tmax).(Part B)
Time frame: From baseline to the end of the 29-day follow-up.
The incidence and titer of anti-drug antibody (ADA).(Part B)
Time frame: From baseline to the end of the 29-day follow-up.
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