A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19

NCT06039163 | Completed Phase 1

• 1 other identifier: HH120-103
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

This is a randomized, double-blind, placebo-controlled Phase 1 study in participants over the 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 dose escalation phase and dose expansion phase.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability: Incidence, frequency, severity, and duration of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAE) and serious adverse events (SAEs), etc.

  From Baseline to Day 12

Secondary Outcomes (3)

• Proportion of participants that achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.

  From Baseline to Day 12

• Median time to achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.

  From Baseline to Day 12

• Median time to sustained clinical recovery.

  From Baseline to Day 12

Study Arms (2)

HH-120

ACTIVE COMPARATOR

Drug: HH-120

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

HH-120 DRUG

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.

HH-120

placebo DRUG

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).

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The escalation phase:
• Participants are aged 18 to 65 years (inclusive at the time of informed consent)
• Participants are mild or moderate COVID-19 patients.
• The expansion phase:
• Participants are ≥18 years of age at the time of randomization.
• Participants are mild or moderate COVID-19 patients.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (4)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Guangzhou Eighth People's,Guangzhou Medical University

Guangzhou, Guangdong, 510440, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: April 16, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

CN (4)