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

NCT06039163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-09-15

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Huahui Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-16
Primary Completion
2022-10-10
Completion
2022-10-10

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06039163 on ClinicalTrials.gov