COVID-19Phase 1NCT05753878

A Study to Evaluate the Safety and Pharmacokinetics of HH-120 Nasal Spray in Healthy Volunteers

A Phase 1 study testing HH-120 nasal spray, PartA cohort 1, HH-120 nasal spray, Part A cohort 2-7 and HH-120 nasal spray, Part A cohort 8-9 in people with COVID-19, run by Huahui Health at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: HH-120 nasal spray, PartA cohort 1, HH-120 nasal spray, Part A cohort 2-7 and HH-120 nasal spray, Part A cohort 8-9
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteChina
Study dates: 8 Nov 2022to 9 Jan 2023
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

Male and female subjects aged 18 to 65 (including 18 and 65 years old);
The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body Mass Index (BMI) = weight (kg)/height2 (m2), BMI is within the range of 18~28kg/m2 (including the critical value);
Normal physical examination, vital signs, laboratory tests and other auxiliary examinations (chest imaging, abdominal B-ultrasound, electrocardiogram, etc.) or abnormality without clinical significance.
Willing and able to give written informed consent.

Who cannot join

Participated in any other clinical research with drug intervention within 4 weeks before screening, or the drug is still in the elimination period (5 half-lives) before screening, whichever is longer;
Have used therapeutic biological agents within 12 weeks before screening, or are within the drug elimination period (5 half-lives) at the time of random administration, whichever is longer;
Have been vaccinated within 12 weeks before screening, or plan to receive BCG or other vaccines during the study or within 12 weeks after the study;
Have used any prescription drugs, non-prescription Chinese herbal medicines or health products within 14 days (inclusive) before the screening;
Have undergone any major surgery within 8 weeks (including 8 weeks) before screening, or need to undergo such surgery during the study period, and deemed by the investigator and the sponsor that such surgery may bring unacceptable risk to the subject.;Physical examination, laboratory abnormalities, and medical history;
Supine systolic blood pressure (SBP) >140mmHg or <90 mmHg, and/or diastolic blood pressure (DBP) >90mmHg or <50 mmHg during the screening period;

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Supine 12-lead electrocardiogram showing QTcF interval > 450 ms (male) or > 470 ms (female). and/or other abnormalities with clinical significance during screening;
History of systemic or respiratory infection within 2 weeks before screening, or concurrent viral or bacterial infection (fever or other symptoms) during screening;
Have received vital organ transplantation (such as heart, lung, liver, kidney, etc.);
Have malignant tumor diseases (excluding malignant tumors that have been cured and have no recurrence within the past 5 years, completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type);
Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), Treponema pallidum antibody and acquired immunodeficiency syndrome (HIV) antibody positive;
History of cardiovascular system, digestive system, kidney, liver, endocrine system, blood and lymphatic system, immune, nervous system or mental disorders or any other significant diseases, or suffer from chronic rhinitis or allergic rhinitis, drug abuse, alcoholism
Have a history of drug abuse or used drugs in the past six months or have a positive urine drug screening;
Have a history of alcoholism or excessive alcohol intake in the past 6 months (drinking 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine), or those who have a positive alcohol breath test; or test Cannot cooperate with non-drinkers during the period;
Known hypersensitivity to any ingredient used in the dosage form of intervention therapy; ever hypersensitivity (regardless of degree) to other monoclonal antibody drugs and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukins, etc.) ; or have a clear past allergy to inhalant allergens (regardless of degree);
History of severe allergic reactions or hypersensitivity reactions, or those with allergic constitution (allergic to multiple drugs and food);
Have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum;
Positive for human chorionic gonadotropin (β-Human Chorionic Gonadotropin, β-HCG) or are breastfeeding;
Have blood losing >400mL in the past 3 months, or have received blood transfusion; or plan to donate blood during the study;
Any other circumstances that the researchers deemed not suitable for participating in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing TongRen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Immunogenicity of HH-120 Nasal Spray in Healthy Subjects

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.

Conditions: COVID-19
Being tested: HH-120 nasal spray, PartA cohort 1, HH-120 nasal spray, Part A cohort 2-7, HH-120 nasal spray, Part A cohort 8-9, HH-120 nasal spray, Part B, Placebo nasal spray, Part B
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HH-120 nasal spray, PartA cohort 1Drug
A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection.
HH-120 nasal spray, Part A cohort 2-7Drug
A single dose of HH-120 nasal spray.
HH-120 nasal spray, Part A cohort 8-9Drug
Two doses of HH-120 nasal spray.
HH-120 nasal spray, Part BDrug
HH-120 nasal spray, 10 times daily for 7 consecutive days.
Placebo nasal spray, Part BOther
Placebo nasal spray, 10 times daily for 7 consecutive days.

Study groups in NCT05753878
Study group	Role	What they receive
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. Receives: Drug: HH-120 nasal spray, PartA cohort 1
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). Receives: Drug: HH-120 nasal spray, Part A cohort 2-7
HH-120 nasal spray, Part A cohort 8-9	Experimental	Nasal/nasopharyngeal samples are collected at 4h (±30 min) , 8h (±30 min). Receives: Drug: HH-120 nasal spray, Part A cohort 8-9
HH-120 nasal spray, Part B	Experimental	Not described Receives: Drug: HH-120 nasal spray, Part B
Placebo nasal spray, Part B	Placebo comparator	Not described Receives: Other: Placebo nasal spray, Part B

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: From baseline to the end of the 29-day follow-up.

Secondary outcomes (5)

The incidence and severity of adverse events and the serious adverse events.(Part A)
Measured: 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)
Measured: From baseline to the end of the 29-day follow-up.
Maximum plasma concentration (Cmax).(Part B)
Measured: From baseline to the end of the 29-day follow-up.
Peak time (Tmax).(Part B)
Measured: From baseline to the end of the 29-day follow-up.
The incidence and titer of anti-drug antibody (ADA).(Part B)
Measured: From baseline to the end of the 29-day follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 20229 Jan 2023

First posted3 Mar 2023
Study start8 Nov 2022
Primary completion9 Jan 2023
Study completion9 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05753878
Sponsor's protocol ID: HH120-NS111
Status last verified: Sep 2023
First submitted: 23 Feb 2023
Last updated: 28 Sep 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Immunogenicity of HH-120 Nasal Spray in Healthy Subjects
ClinicalTrials.gov ID: NCT05753878
Acronym / sponsor ID: HH120-NS111
Conditions: COVID-19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Huahui HealthIndustry (pharma, biotech, devices)
Study start: 8 Nov 2022 (actual)
Primary completion: 9 Jan 2023 (actual)
Study completion: 9 Jan 2023 (actual)
First posted: 3 Mar 2023 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
HH-120 nasal spray, Part A cohort 1	Experimental	Drug: HH-120 nasal spray, PartA cohort 1Nasal 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	Drug: HH-120 nasal spray, Part A cohort 2-7Nasal/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	Drug: HH-120 nasal spray, Part A cohort 8-9Nasal/nasopharyngeal samples are collected at 4h (±30 min) , 8h (±30 min).
HH-120 nasal spray, Part B	Experimental	Drug: HH-120 nasal spray, Part B
Placebo nasal spray, Part B	Placebo comparator	Other: Placebo nasal spray, Part B

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male and female subjects aged 18 to 65 (including 18 and 65 years old);
The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body Mass Index (BMI) = weight (kg)/height2 (m2), BMI is within the range of 18~28kg/m2 (including the critical value);
Normal physical examination, vital signs, laboratory tests and other auxiliary examinations (chest imaging, abdominal B-ultrasound, electrocardiogram, etc.) or abnormality without clinical significance.
Willing and able to give written informed consent.

Key exclusion criteria (20 listed)

Participated in any other clinical research with drug intervention within 4 weeks before screening, or the drug is still in the elimination period (5 half-lives) before screening, whichever is longer;
Have used therapeutic biological agents within 12 weeks before screening, or are within the drug elimination period (5 half-lives) at the time of random administration, whichever is longer;
Have been vaccinated within 12 weeks before screening, or plan to receive BCG or other vaccines during the study or within 12 weeks after the study;
Have used any prescription drugs, non-prescription Chinese herbal medicines or health products within 14 days (inclusive) before the screening;
Have undergone any major surgery within 8 weeks (including 8 weeks) before screening, or need to undergo such surgery during the study period, and deemed by the investigator and the sponsor that such surgery may bring unacceptable risk to the subject.;Physical examination, laboratory abnormalities, and medical history;

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 nasal spray, PartA cohort 1A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection.	Drug	HH-120 nasal spray, Part A cohort 1
HH-120 nasal spray, Part A cohort 2-7A single dose of HH-120 nasal spray.	Drug	HH-120 nasal spray, Part A cohort 2-7
HH-120 nasal spray, Part A cohort 8-9Two doses of HH-120 nasal spray.	Drug	HH-120 nasal spray, Part A cohort 8-9
HH-120 nasal spray, Part BHH-120 nasal spray, 10 times daily for 7 consecutive days.	Drug	HH-120 nasal spray, Part B
Placebo nasal spray, Part BPlacebo nasal spray, 10 times daily for 7 consecutive days.	Other	Placebo nasal spray, Part B

Primary outcome

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)
Time frame: 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)
Time frame: 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)
Time frame: From baseline to the end of the 29-day follow-up.

5 secondary outcomes

The incidence and severity of adverse events and the serious adverse events.(Part A)
Time frame: 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)
Time frame: From baseline to the end of the 29-day follow-up.
Maximum plasma concentration (Cmax).(Part B)
Time frame: From baseline to the end of the 29-day follow-up.
Peak time (Tmax).(Part B)
Time frame: From baseline to the end of the 29-day follow-up.
The incidence and titer of anti-drug antibody (ADA).(Part B)
Time frame: From baseline to the end of the 29-day follow-up.

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 28 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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 20 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 28 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 China. 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. Some participants in this study may receive a placebo. 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?

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) (time frame: From baseline to the end of the 7-day follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05753878.

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 28 Sep 2023.