1.
ClinicalTrials.gov; 08/09/2023; TrialID: NCT06039163
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06039163
ABSTRACT
Condition:
COVID-19Intervention:
Drug: HH-120;Drug: placeboPrimary outcome:
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.Criteria:
Inclusion Criteria:
- The escalation phase:
1. Participants are aged 18 to 65 years (inclusive at the time of informed consent)
2. Participants are mild or moderate COVID-19 patients.
3. Participants have one or more mild or moderate COVID 19-related symptoms as
defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the
onset of symptoms = 3 days prior to the randomization.
- The expansion phase:
1. Participants are =18 years of age at the time of randomization.
2. Participants are mild or moderate COVID-19 patients.
3. Participants have one or more mild or moderate COVID 19-related symptoms as
defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the
onset of symptoms = 5 days prior to the randomization.
Exclusion Criteria:
- 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.
2.
ClinicalTrials.gov; 27/03/2023; TrialID: NCT05787418
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05787418
ABSTRACT
Condition:
COVID-19Intervention:
Drug: HH-120 Nasal Spray;Drug: PlaceboPrimary outcome:
The incidence of symptomatic SARS-CoV-2 infectionCriteria:
Inclusion Criteria:
- 12 to 85 years old.
- Participants with potential exposure to index patients (with known positive result of
qRT-PCR or rapid antigen test [RAT]).
- Participants will be randomized no longer than 48 hours from the onset of the COVID-19
related symptom of the index patients.
- Participants with a negative RAT result within 2 hours prior to randomization.
- Fertile participants must agree to use a highly effective method of contraception.
- Participants being able and willing to provide informed consent prior to any
study-specific procedure.
Exclusion Criteria:
- Those with high risk of cardiac events, or severe abnormal functions of liver, kidney,
lung, brain and other organs and are deemed as unsuitable to participate in the study
(except for those subjects with kidney failure but received regular dialysis, or those
with liver dysfunction but stabilized after treatment evaluated by the evaluation of
the investigators).
- Those comorbid with asthma.
- Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
- Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3
months prior to randomization.
- Those who experienced symptom of upper respiratory tract infection within 2 weeks
prior to randomization, such as nasal congestion, sore throat, shortness of breath
(dyspnea), cough, fatigue, fever, headache, etc.
- Known history of allergy or reaction to any component of the study drug formulation.
- Those who has received other treatment with anti-COVID-19 indication (within 1 month
or 5 half-life period prior to randomization, whichever occurs first).
- Participants with nasal disease that is inconvenient or intolerant of nasal spray
administration.
- Other reasons considered by the investigator to be unsuitable for the study.
3.
ClinicalTrials.gov; 23/02/2023; TrialID: NCT05753878
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05753878
ABSTRACT
Condition:
COVID-19Intervention:
Drug: HH-120 nasal spray, PartA cohort 1;Drug: HH-120 nasal spray, Part A cohort 2-7;Drug: HH-120 nasal spray, Part A cohort 8-9;Drug: HH-120 nasal spray, Part B;Other: Placebo nasal spray, Part BPrimary 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);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);The incidence and severity of adverse events and the serious adverse events.(Part B)Criteria:
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 (ß-Human Chorionic Gonadotropin, ß-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.
4.
ClinicalTrials.gov; 31/01/2023; TrialID: NCT05713318
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05713318
ABSTRACT
Condition:
COVID-19Intervention:
Drug: HH-120 nasal spray;Drug: HH-120 nasal spray;Drug: Placebo Comparator;Drug: Placebo ComparatorPrimary outcome:
Changes of viral load compared to the baselineCriteria:
Inclusion Criteria:
- Participants who are =18 years of age .
- Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of
SARS-CoV-2 infection as determined by PCR or antigen test.
- Participants who agree to use highly effective methods of contraception. Women of
childbearing potential (WOCBP) must have a negative urine pregnancy test result.
- Participants who are willing and able to provide written informed consent, or with a
legal representative who can provide informed consent.
Exclusion Criteria:
- Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.),
active bacterial, fungal, viral, or other infection (except COVID 19) that in the
opinion of the Investigator could constitute a risk when taking the study
intervention.
- Bronchial asthma or chronic obstructive pulmonary disease (COPD).
- Urgent or expected need for nasal high-flow oxygen therapy or positive pressure
ventilation, invasive mechanical ventilation or Extracorporeal membrane
oxygenation(ECMO).
- Have prior use (unless required as rescue medication) of any of the following
treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved
treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2,
intravenous immune globulin (IVIG) (any indication), where prior use is defined as the
past 30 days or less than 5 half lives of the investigational product (whichever is
longer) from Screening.
- 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 study intervention.
5.
ClinicalTrials.gov; 19/10/2021; TrialID: NCT05116865
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05116865
ABSTRACT
Condition:
COVID-19 Respiratory InfectionIntervention:
Biological: HH-120 Dose 1;Biological: HH-120 Dose 2;Biological: HH-120 Dose 3;Drug: PlaceboPrimary outcome:
Number of participants with treatment emergent adverse events (TEAEs);Severity of treatment emergent adverse events (TEAEs)as assessed by CTCAE v5.0;Duration of treatment emergent adverse events (TEAEs);Number of participants with serious adverse events (SAEs);Severity of serious adverse events (SAEs) as assessed by CTCAE v5.0;Duration of serious adverse events (SAEs);Number of participants with abnormal clinically significant physical examination findings;Number of participants with abnormal clinically significant electrocardiogram (ECG);Number of participants with clinically significant change in vital signs from baseline;Changes in the spirometry score from Baseline;Number of participants with abnormal clinically significant clinical laboratory parametersCriteria:
Inclusion Criteria:
1. Healthy male or female volunteers aged 18 to 65 years (both inclusive)
2. 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.
3. Participants must be a non-smoker and must not have used any tobacco products within
90 days prior to Screening.
4. 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.
5. Participants must have clinical laboratory values within normal range.
6. 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.
7. Males must not donate sperm for at least 90 days after the last dose of IP.
8. Participants must have the ability and willingness to attend the necessary visits to
the CRU.
Exclusion Criteria:
1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period.
2. 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.
3. Presence of any underlying physical or psychological medical condition
4. 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.
5. History or evidence o f any anatomical airway defect, which in the opinion of the PI,
may impact inhalation.
6. Abnormal spirometry findings at Screening that are considered by the PI to be
clinically significant, including FEV1 < 80% or FVC < 80%.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. A personal history of unexplained blackouts or fainting or known risk factors for
Torsade de Pointes (eg, hypokalemia, heart failure).
13. 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).
14. 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.
15. Confirmed (eg, 2 consecutive triplicate measurements) average resting HR > 100 or < 45
beats per minute at Screening.
16. 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).
17. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or
human immunodeficiency virus (HIV) antibody at Screening.
18. 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.
19. 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).
20. Use of any IP or medical device within 30 days prior to screening.
21. 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.