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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HH-120 nasal spray, Part A cohort 1 | Experimental | Nasal endoscopic examination is performed at 3min (±2 min), 30min (±5 min), 1h (±10 min), and 2h (±10 min) after dosing. |
|
| HH-120 nasal spray, Part A cohort 2-7 | Experimental | Nasal/nasopharyngeal samples are collected at 3min (±2 min) , 1h (±10 min) ,2h (±10 min),4h (±30 min),8h (±30 min),24h (±30 min). |
|
| HH-120 nasal spray, Part A cohort 8-9 | Experimental | Nasal/nasopharyngeal samples are collected at 4h (±30 min) , 8h (±30 min). |
|
| HH-120 nasal spray, Part B | Experimental |
| |
| Placebo nasal spray, Part B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HH-120 nasal spray, PartA cohort 1 | Drug | A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | From baseline to the end of the 29-day follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events and the serious adverse events.(Part A) | 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) | From baseline to the end of the 29-day follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| The in vitro SARS-CoV-2 neutralization activity of nasal and nasopharyngeal swab samples at different time points after dosing.(Part A) | From baseline to the end of the 7 days follow-up. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing TongRen Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China |
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| HH-120 nasal spray, Part A cohort 2-7 | Drug | A single dose of HH-120 nasal spray. |
|
| HH-120 nasal spray, Part A cohort 8-9 | Drug | Two doses of HH-120 nasal spray. |
|
| HH-120 nasal spray, Part B | Drug | HH-120 nasal spray, 10 times daily for 7 consecutive days. |
|
| Placebo nasal spray, Part B | Other | Placebo nasal spray, 10 times daily for 7 consecutive days. |
|
| Maximum plasma concentration (Cmax).(Part B) | From baseline to the end of the 29-day follow-up. |
| Peak time (Tmax).(Part B) | From baseline to the end of the 29-day follow-up. |
| The incidence and titer of anti-drug antibody (ADA).(Part B) | From baseline to the end of the 29-day follow-up. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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