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

September 25, 2023 updated by: Huahui Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HH-120 nasal spray, Part A cohort 1
Nasal endoscopic examination is performed at 3min (±2 min), 30min (±5 min), 1h (±10 min), and 2h (±10 min) after dosing.
Drug: HH-120 nasal spray, PartA cohort 1
A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection.
Experimental: HH-120 nasal spray, Part A cohort 2-7
Nasal/nasopharyngeal samples are collected at 3min (±2 min) , 1h (±10 min) ,2h (±10 min),4h (±30 min),8h (±30 min),24h (±30 min).
Drug: HH-120 nasal spray, Part A cohort 2-7
A single dose of HH-120 nasal spray.
Experimental: HH-120 nasal spray, Part A cohort 8-9
Nasal/nasopharyngeal samples are collected at 4h (±30 min) , 8h (±30 min).
Drug: HH-120 nasal spray, Part A cohort 8-9
Two doses of HH-120 nasal spray.
Experimental: HH-120 nasal spray, Part B
Drug: HH-120 nasal spray, Part B
HH-120 nasal spray, 10 times daily for 7 consecutive days.
Placebo Comparator: Placebo nasal spray, Part B
Other: Placebo nasal spray, Part B
Placebo nasal spray, 10 times daily for 7 consecutive days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
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.
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.
From baseline to the end of the 29-day follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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.
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.
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.
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.
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.
From baseline to the end of the 29-day follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
The in vitro SARS-CoV-2 neutralization activity of nasal and nasopharyngeal swab samples at different time points after dosing.(Part A)
Time Frame: From baseline to the end of the 7 days follow-up.
From baseline to the end of the 7 days follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huahui Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HH120-NS111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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