This is a randomized, double-blind, placebo-controlled Phase 1 study in participants overthe age of 18 years with mild to moderate COVID-19. This study aims to assess the safety,tolerability and preliminary antiviral effect of HH-120. This study includes doseescalation phase and dose expansion phase.
Not Provided
Drug: HH-120
Participants randomized to active treatment in escalation phase will receive HH-120
administered via inhalation for 5 consecutive days (Day 1 to Day 5). Planned dose levels
to be used for the escalation phase of the study are 50 (BID), 50 (TID), and 100 (BID)
mg. The expansion phase will begin once the recommended dose for expansion phase
determined, based on safety and preliminary efficacy data from the escalation phase.
Drug: placebo
Participants randomized to placebo group in escalation and expansion phase will receive
placebo administered via inhalation for 5 consecutive days (Day 1 to Day 5).
Inclusion Criteria:
- The escalation phase:
1. Participants are aged 18 to 65 years (inclusive at the time of informed
consent)
2. Participants are mild or moderate COVID-19 patients.
3. Participants have one or more mild or moderate COVID 19-related symptoms as
defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the
onset of symptoms ≤ 3 days prior to the randomization.
- The expansion phase:
1. Participants are ≥18 years of age at the time of randomization.
2. Participants are mild or moderate COVID-19 patients.
3. Participants have one or more mild or moderate COVID 19-related symptoms as
defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the
onset of symptoms ≤ 5 days prior to the randomization.
Exclusion Criteria:
- Pregnant or lactating at Screening or planning to become pregnant (self or partner)
at any time during the study, including the follow-up period.
- Prior or ongoing medical conditions, medical history, physical findings, or
laboratory abnormality that, in the PI's (or delegate's) opinion, could adversely
affect the safety of the participant or that might interfere with the conduct of the
study.
- Presence of any underlying physical or psychological medical condition that, in the
opinion of the PI, would make it unlikely that the participant will comply with the
protocol or complete the study per protocol.
- Have known allergies to any of the components used in the formulation of the study
intervention.
Beijing Ditan Hospital,Capital Medical University
Beijing 1816670, Beijing Municipality 2038349, China
Guangzhou Eighth People's,Guangzhou Medical University
Guangzhou 1809858, Guangdong 1809935, China
The First Hospital of Jilin University
Changchun 2038180, Jilin 2036500, China
Huashan Hospital affiliated to Fudan University
Shanghai 1796236, Shanghai Municipality 1796231, China
Not Provided