COVID-19 Respiratory InfectionPhase 1NCT05116865
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers
A Phase 1 study testing HH-120 Dose 1, HH-120 Dose 2 and HH-120 Dose 3 in people with COVID-19 Respiratory Infection, run by Huahui Health at 1 site in Australia.
Trial summary
This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of HH-120 in healthy adult volunteers. HH-120 is a novel inhalable biologic being developed for COVID-19 treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- HH-120 Dose 1, HH-120 Dose 2 and HH-120 Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2021to 2 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers aged 18 to 65 years (both inclusive)
- Participants must have a body mass index between ≥ 18.0 and ≤ 32 .0 kg/m2 and a bodyweight of at least 45 kg at Screening.
- Participants must be a non-smoker and must not have used any tobacco products within 90 days prior to Screening.
- Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of IP.
- Participants must have clinical laboratory values within normal range.
- Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from Screening until study completion, including the follow-up period.
- Males must not donate sperm for at least 90 days after the last dose of IP.
- Participants must have the ability and willingness to attend the necessary visits to the CRU.
Who cannot join
- 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
- Pre-existing severe obstructive disease of the respiratory system such as chronic obstructive pulmonary disease or asthma , including resolved childhood asthma, which may impact inhalation as judged by the PI, delegate, or Sponsor.
- History or evidence o f any anatomical airway defect, which in the opinion of the PI, may impact inhalation.
- Abnormal spirometry findings at Screening that are considered by the PI to be clinically significant, including FEV1 < 80% or FVC < 80%.
Show all 21Show fewer
- Blood donation of > 500 mL or significant blood loss within 60 days prior to the first IP administration or plasma donation within 7 days prior to IP administration.
- Systemic or respiratory infection within 2 weeks before the Screening visit or fever (tympanic temperature > 37.5°C) or symptomatic viral or bacterial infection at time of Screening.
- Current infection with SARS-CoV-2, infection within the 2 weeks prior to Screening, or a history of SARS-CoV-2 infection plus symptoms of post-COVID syndrome.
- History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the IP.
- History of malignancy, except for non-melanoma skin cancer, excised more than 2 years ago and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
- A personal history of unexplained blackouts or fainting or known risk factors for Torsade de Pointes (eg, hypokalemia, heart failure).
- Abnormal 12-lead ECG findings at Screening that are considered by the PI to be clinically significant, including arrhythmias or marked QT interval abnormalities (QTcF < 300 msec or ≥ 450 msec at Screening).
- Confirmed (eg, 2 consecutive triplicate measurements) average systolic blood pressure (SBP) > 140 or < 90 mmHg, and diastolic blood pressure (DBP) > 90 or < 45 mmHg at Screening.
- Confirmed (eg, 2 consecutive triplicate measurements) average resting HR > 100 or < 45 beats per minute at Screening.
- Vaccination with a live vaccine within the 4 weeks prior to Screening or that is planned within 4 weeks of dosing, and any non-live vaccination within the 2 weeks prior to Screening, or that is planned within 2 weeks of dosing or planned during study participation (including vaccines for COVID-19).
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
- Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, benzodiazepines, opiates, cocaine, and cotinine), or alcohol breath test at Screening or Day -1.
- Participants with a history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 6 months (by self-declaration).
- Use of any IP or medical device within 30 days prior to screening.
- Use of any prescription drugs for 14 days prior to dosing or over the counter medication, herbal remedies, supplements or vitamins 7 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of Inhaled HH-120 Aerosol in Healthy Volunteers
This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of HH-120 in healthy adult volunteers. HH-120 is a novel inhalable biologic being developed for COVID-19 treatment. The study aims to evaluate the safety, tolerability and pharmacokinetic profile of HH-120 administered by aerosol inhalation after single and multiple ascending doses.
Read the detailed description
Approximately 48 participants will be sequentially enrolled into either 1 of 3 SAD cohorts (n=8 per cohort), or 1 of 3 MAD cohorts (n= 8 per cohort). An adaptive dose escalation schedule will be employed for both SAD and MAD parts of the study.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- HH-120 Dose 1, HH-120 Dose 2, HH-120 Dose 3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-120 Dose 1Biological
Also called HH-120
Dose level 1 of HH-120
HH-120 Dose 2Biological
Also called HH-120
Dose level 2 of HH-120
HH-120 Dose 3Biological
Also called HH-120
Dose level 3 of HH-120
PlaceboDrug
Placebo to match
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose Cohort A1 | Experimental | Subjects will receive a single dose of either dose level 1 of HH-120 or placebo Receives: Biological: HH-120 Dose 1; Drug: Placebo |
| Single Ascending Dose Cohort A2 | Experimental | Subjects will receive a single dose of either dose level 2 of HH-120 or placebo Receives: Biological: HH-120 Dose 2; Drug: Placebo |
| Single Ascending Dose Cohort A3 | Experimental | Subjects will receive a single dose of either dose level 3 of HH-120 or placebo Receives: Biological: HH-120 Dose 3; Drug: Placebo |
| Multiple Ascending Doses Cohort B1 | Experimental | Subjects will receive multiple doses of either Dose level 1of HH-120 or placebo Receives: Biological: HH-120 Dose 1; Drug: Placebo |
| Multiple Ascending Doses Cohort B2 | Experimental | Subjects will receive multiple doses of either Dose level 2 of HH-120 or placebo Receives: Biological: HH-120 Dose 2; Drug: Placebo |
| Multiple Ascending Doses Cohort B3 | Experimental | Subjects will receive multiple doses of either Dose level 3 of HH-120 or placebo Receives: Biological: HH-120 Dose 3; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (TEAEs)
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Severity of treatment emergent adverse events (TEAEs)as assessed by CTCAE v5.0
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Duration of treatment emergent adverse events (TEAEs)
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Number of participants with serious adverse events (SAEs)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Severity of serious adverse events (SAEs) as assessed by CTCAE v5.0
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Duration of serious adverse events (SAEs)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Number of participants with abnormal clinically significant physical examination findings
Complete and symptom directed physical examination will be performed
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Number of participants with abnormal clinically significant electrocardiogram (ECG)
Single resting 12- lead ECGs will be collected
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Number of participants with clinically significant change in vital signs from baseline
Vital signs include heart rate, blood pressure, respiratory rate and tympanic temperature
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Changes in the spirometry score from Baseline
Measured by Forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) after dosing
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Number of participants with abnormal clinically significant clinical laboratory parameters
Clinical laboratory test include hematology, coagulation, biochemistry and urinalysis
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Secondary outcomes (13)
Cmax in SAD and MAD
Maximum observed HH-120 concentration
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Tmax in SAD and MAD
Time to the maximum observed HH-120 concentration
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
t1/2 in SAD and MAD part
Terminal elimination half life calculated as ln (2)/λz
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
AUC0-last
Area under the plasma concentration-time curve from time zero (from the start of inhalation time) to the last time point with measurable analyte concentration
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
AUC0-inf
AUC from time zero (from the start of inhalation time) extrapolated to infinity
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
%AUCextrap
The percentage of the AUC that has been extrapolated beyond the last observed data point
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Kel or λz
Apparent terminal elimination rate constant, calculated by linear regression of the terminal linear portion of the log concentration vs time curve
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
CL/F
Apparent total body clearance
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Vz/F in SAD
Apparent volume of distribution during the terminal phase
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
CL/Fss in MAD
Apparent total plasma clearance at steady state
Measured: Day 1-Day 22
Vz/Fss in MAD
Apparent terminal volume of distribution at steady state
Measured: Day1- Day 22
Accumulation ratio (RA)
AUC0-24 hours on Day 7/AUC0-24 hours on Day 1
Measured: Day 1- Day 7
Immunogenicity of HH-120
To determine the presence and levels of anti-drug antibody (ADA).
Measured: Day 1- Day 15 (SAD) or Day 22 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Nov 2021
- Primary completion26 May 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongqing Lin, Study director, Huahui Health Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116865
- Sponsor's protocol ID
- HH120-101
- Status last verified
- Sep 2023
- First submitted
- 19 Oct 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of Inhaled HH-120 Aerosol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05116865
- Acronym / sponsor ID
- HH120-101
- Conditions
- COVID-19 Respiratory Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of HH-120 in healthy adult volunteers. HH-120 is a novel inhalable biologic being developed for COVID-19 treatment. The study aims to evaluate the safety, tolerability and pharmacokinetic profile of HH-120 administered by aerosol inhalation after single and multiple ascending doses.
Detailed description
Approximately 48 participants will be sequentially enrolled into either 1 of 3 SAD cohorts (n=8 per cohort), or 1 of 3 MAD cohorts (n= 8 per cohort). An adaptive dose escalation schedule will be employed for both SAD and MAD parts of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose Cohort A1 | Experimental | Biological: HH-120 Dose 1, Drug: PlaceboSubjects will receive a single dose of either dose level 1 of HH-120 or placebo |
| Single Ascending Dose Cohort A2 | Experimental | Biological: HH-120 Dose 2, Drug: PlaceboSubjects will receive a single dose of either dose level 2 of HH-120 or placebo |
| Single Ascending Dose Cohort A3 | Experimental | Biological: HH-120 Dose 3, Drug: PlaceboSubjects will receive a single dose of either dose level 3 of HH-120 or placebo |
| Multiple Ascending Doses Cohort B1 | Experimental | Biological: HH-120 Dose 1, Drug: PlaceboSubjects will receive multiple doses of either Dose level 1of HH-120 or placebo |
| Multiple Ascending Doses Cohort B2 | Experimental | Biological: HH-120 Dose 2, Drug: PlaceboSubjects will receive multiple doses of either Dose level 2 of HH-120 or placebo |
| Multiple Ascending Doses Cohort B3 | Experimental | Biological: HH-120 Dose 3, Drug: PlaceboSubjects will receive multiple doses of either Dose level 3 of HH-120 or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy male or female volunteers aged 18 to 65 years (both inclusive)
- Participants must have a body mass index between ≥ 18.0 and ≤ 32 .0 kg/m2 and a bodyweight of at least 45 kg at Screening.
- Participants must be a non-smoker and must not have used any tobacco products within 90 days prior to Screening.
- Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening and/or before administration of the initial dose of IP.
- Participants must have clinical laboratory values within normal range.
Key exclusion criteria (21 listed)
- 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
- Pre-existing severe obstructive disease of the respiratory system such as chronic obstructive pulmonary disease or asthma , including resolved childhood asthma, which may impact inhalation as judged by the PI, delegate, or Sponsor.
- History or evidence o f any anatomical airway defect, which in the opinion of the PI, may impact inhalation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HH-120 Dose 1Also: HH-120Dose level 1 of HH-120 | Biological | Multiple Ascending Doses Cohort B1, Single Ascending Dose Cohort A1 |
| HH-120 Dose 2Also: HH-120Dose level 2 of HH-120 | Biological | Multiple Ascending Doses Cohort B2, Single Ascending Dose Cohort A2 |
| HH-120 Dose 3Also: HH-120Dose level 3 of HH-120 | Biological | Multiple Ascending Doses Cohort B3, Single Ascending Dose Cohort A3 |
| PlaceboPlacebo to match | Drug | Multiple Ascending Doses Cohort B1, Multiple Ascending Doses Cohort B2, Multiple Ascending Doses Cohort B3, Single Ascending Dose Cohort A1, Single Ascending Dose Cohort A2, Single Ascending Dose Cohort A3 |
Primary outcome
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
Severity of treatment emergent adverse events (TEAEs)as assessed by CTCAE v5.0
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
Duration of treatment emergent adverse events (TEAEs)
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE that started on or after the first study treatment or that worsened after the first study treatment will be regarded as TEAEs.
Number of participants with serious adverse events (SAEs)
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
Severity of serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
Duration of serious adverse events (SAEs)
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect
Number of participants with abnormal clinically significant physical examination findings
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Complete and symptom directed physical examination will be performed
Number of participants with abnormal clinically significant electrocardiogram (ECG)
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Single resting 12- lead ECGs will be collected
Number of participants with clinically significant change in vital signs from baseline
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Vital signs include heart rate, blood pressure, respiratory rate and tympanic temperature
Changes in the spirometry score from Baseline
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Measured by Forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) after dosing
Number of participants with abnormal clinically significant clinical laboratory parameters
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Clinical laboratory test include hematology, coagulation, biochemistry and urinalysis
13 secondary outcomes
Cmax in SAD and MAD
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Tmax in SAD and MAD
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
t1/2 in SAD and MAD part
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
AUC0-last
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
AUC0-inf
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
%AUCextrap
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Kel or λz
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
CL/F
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Vz/F in SAD
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
CL/Fss in MAD
Time frame: Day 1-Day 22
Vz/Fss in MAD
Time frame: Day1- Day 22
Accumulation ratio (RA)
Time frame: Day 1- Day 7
Immunogenicity of HH-120
Time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongqing Lin study director
Huahui Health Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HH-120 Dose 1, HH-120 Dose 2 and HH-120 Dose 3 in people with COVID-19 Respiratory Infection, run by Huahui Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent adverse events (TEAEs) (time frame: Day 1- Day 15 (SAD) or Day 22 (MAD)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.