Respiratory Syncytial Virus InfectionsPhase 3NCT06363370
Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections
A Phase 3 study testing Human interferon α1b Inhalation Solution in people with Respiratory Syncytial Virus Infections, run by Kexing Biopharm Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Human interferon α1b Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-[(37 weeks-fetal age)/4], gender is not limited;
- Comply with the following diagnostic criteria:
- 1) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative QPCR detection; Show the positive of RSV infection; 2) Cough and/or asthma, lung auspicious pitch and/or wet sounds; 3) Chest imaging examination shows the dot -shaped shadow and/or thick lung texture/slightly/more and/or emphysema and/or the signs of inflammation around the bronchial.
- 3. Signing the informed consent of the child's disease distance within 72 hours (cough, breathing, fever); 4. The severity of the condition of capillary bronchitis is moderate or severe; 5. The parents of the child, or the legal guardian, or the legal guardians have fully understood the relevant information of this experiment and the possible benefits and risks of the subject's expectations, and agreed that the child to participate in this experiment and voluntarily signed the informed consent.
Who cannot join
- There is a history of drug allergies (interferon products, related solutions formula components, etc.), or those with a history of specific allergies (asthma, based on the "eczema area and severity index" (EASI for short) scoring method as severe eczema, etc.), Or those who are diagnosed by doctors clearly diagnose (such as allergies to two or more drugs, food and pollen);
- Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation;
- Those who have genetic metabolic diseases;
- A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；
- Any disabled drugs (disabled drugs include interferon, Libavarin and the drug instructions within 72 hours before the medication are expected to specify the Chinese medicines with antiviral effects, etc.) and within 24 hours before the administration of administration Children with sugar hormones used in inhalation and body;
- There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia.
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- There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.;
- Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia;
- Candid's with functional disorders and lesions with epilepsy or other central nervous system, such as meningitis, toxic or hypoxic encephalopathy;
- During the filter, it is accompanied by severe diarrhea, moderate malnutrition, anemia, and blood system disease;
- During the screening, the thoracic effusion, pydion and pus, and pus, etc.;
- Merce able goose sores suspected mold infection during screening；
- The laboratory inspection is abnormal during screening:1) White blood cell count>14x109/L (or normal value of normal value) or neutral granulocyte ratio> 70%, and researchers comprehensively judge suspects as merging bacterial infections;2) Excisibility of liver function test: Alanine aminotransferase (ALT) or permine aminamidase (AST)> The upper limit of the normal value is 2 times, or the total biliary erythrin> 1.5 times the upper limit of the normal value;3) Blood routine abnormalities: white blood cell count <3.5X109/L and/or platelet count≤100x109/L；
- Extremely irritable, drowsiness, coma, or those who may need ventilator to assist breathing;
- After the history of the history of the disease, the child known (or the mother who is younger than 6 months old) is HIV -positive, or the researcher is highly suspected of being HIV -positive;
- In the random 30 days before the randomly participated in any drug clinical trial or those who used research drugs;
- Volunteers may not be able to complete this study or researchers who believe that they are not suitable for participating in this clinical trial due to various reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ling Cao contact
China1 site, 1 recruiting
- Recruiting
Children's Hospital, Capital Institute of Pediatrics
Beijing, Beijing Municipality, 100000
Ling Cao, MD, 13910610319
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children.
To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.
Read the detailed description
The study has been divided into two parts, 60 subjects will be randomly assigned to the 4μg/kg dose group or 6μg/kg dose group or the blank control group, to receive nebulized GB05 therapy, twice daily for no more than 7 days. After comprehensive evaluation of effectiveness and safety, and confirmation of the optimal dose, the sample size will be re-calculated to enter the second part of the study.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Human interferon α1b Inhalation Solution, Inhalation Solution Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human interferon α1b Inhalation SolutionDrug
Participants will receive Human interferon α1b Inhalation Solution
Inhalation Solution PlaceboDrug
Participants will receive Inhalation Solution Placebo
| Study group | Role | What they receive |
|---|---|---|
| Human interferon α1b Inhalation Solution （4ug/kg） | Experimental | Participants will receive Human interferon α1b Inhalation Solution 4ug/kg twice daily for no more than 7 days. Receives: Drug: Human interferon α1b Inhalation Solution |
| Human interferon α1b Inhalation Solution（6ug/kg） | Experimental | Participants will receive Human interferon α1b Inhalation Solution 6ug/kg twice daily for no more than 7 days. Receives: Drug: Human interferon α1b Inhalation Solution |
| Inhalation Solution Placebo | Placebo comparator | Participants will receive Placebo twice daily for no more than 7 days. Receives: Drug: Inhalation Solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wang bronchiolitis score chanced by percentage from baseline
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Measured: day 5
Wang bronchiolitis score chanced by percentage from baseline
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Measured: day 1 to day of last administration (except day 5)
Wang bronchiolitis score of 0 in proportion
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Measured: day 5
Wang bronchiolitis score total score < 5 points
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Measured: day 5
Wang bronchiolitis score, the first time the total score reaches < 5 points
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Measured: day 5
Secondary outcomes (1)
RSV viral load
qPCR test
Measured: From predose to 120 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start27 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kexing Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363370
- Sponsor's protocol ID
- KXZY-GB05-201
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children.
- ClinicalTrials.gov ID
- NCT06363370
- Acronym / sponsor ID
- KXZY-GB05-201
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Kexing Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Apr 2024 (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.
To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection.
Detailed description
The study has been divided into two parts, 60 subjects will be randomly assigned to the 4μg/kg dose group or 6μg/kg dose group or the blank control group, to receive nebulized GB05 therapy, twice daily for no more than 7 days. After comprehensive evaluation of effectiveness and safety, and confirmation of the optimal dose, the sample size will be re-calculated to enter the second part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Human interferon α1b Inhalation Solution （4ug/kg） | Experimental | Drug: Human interferon α1b Inhalation SolutionParticipants will receive Human interferon α1b Inhalation Solution 4ug/kg twice daily for no more than 7 days. |
| Human interferon α1b Inhalation Solution（6ug/kg） | Experimental | Drug: Human interferon α1b Inhalation SolutionParticipants will receive Human interferon α1b Inhalation Solution 6ug/kg twice daily for no more than 7 days. |
| Inhalation Solution Placebo | Placebo comparator | Drug: Inhalation Solution PlaceboParticipants will receive Placebo twice daily for no more than 7 days. |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-[(37 weeks-fetal age)/4], gender is not limited;
- Comply with the following diagnostic criteria:
- 1) RSV real -time reversal transcript polymerase chain reaction (RT PCR) positive, or quantitative QPCR detection; Show the positive of RSV infection; 2) Cough and/or asthma, lung auspicious pitch and/or wet sounds; 3) Chest imaging examination shows the dot -shaped shadow and/or thick lung texture/slightly/more and/or emphysema and/or the signs of inflammation around the bronchial.
- 3. Signing the informed consent of the child's disease distance within 72 hours (cough, breathing, fever); 4. The severity of the condition of capillary bronchitis is moderate or severe; 5. The parents of the child, or the legal guardian, or the legal guardians have fully understood the relevant information of this experiment and the possible benefits and risks of the subject's expectations, and agreed that the child to participate in this experiment and voluntarily signed the informed consent.
Key exclusion criteria (17 listed)
- There is a history of drug allergies (interferon products, related solutions formula components, etc.), or those with a history of specific allergies (asthma, based on the "eczema area and severity index" (EASI for short) scoring method as severe eczema, etc.), Or those who are diagnosed by doctors clearly diagnose (such as allergies to two or more drugs, food and pollen);
- Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation;
- Those who have genetic metabolic diseases;
- A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen)；
- Any disabled drugs (disabled drugs include interferon, Libavarin and the drug instructions within 72 hours before the medication are expected to specify the Chinese medicines with antiviral effects, etc.) and within 24 hours before the administration of administration Children with sugar hormones used in inhalation and body;
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 |
|---|---|---|
| Human interferon α1b Inhalation SolutionParticipants will receive Human interferon α1b Inhalation Solution | Drug | Human interferon α1b Inhalation Solution （4ug/kg）, Human interferon α1b Inhalation Solution（6ug/kg） |
| Inhalation Solution PlaceboParticipants will receive Inhalation Solution Placebo | Drug | Inhalation Solution Placebo |
Primary outcome
Wang bronchiolitis score chanced by percentage from baseline
Time frame: day 5
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Wang bronchiolitis score chanced by percentage from baseline
Time frame: day 1 to day of last administration (except day 5)
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Wang bronchiolitis score of 0 in proportion
Time frame: day 5
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Wang bronchiolitis score total score < 5 points
Time frame: day 5
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
Wang bronchiolitis score, the first time the total score reaches < 5 points
Time frame: day 5
The Wang bronchiolitis score consists of four sections (respiratory rate, stridor, respiratory muscle depression, general symptoms), and the severity of the patient's condition is from low to high on a scale of 0 to 12 on the scale. A score of < 5 indicates that the patient is mild, a score of 5-9 indicates that the patient is moderately ill, and a score of ≥9 indicates that the patient is severe.
1 secondary outcome
RSV viral load
Time frame: From predose to 120 hours postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ling Cao contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human interferon α1b Inhalation Solution in people with Respiratory Syncytial Virus Infections, run by Kexing Biopharm Co., Ltd. at 1 site in China.
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 17 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajun Xu (86-18851892277, xujiajun@kexing.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wang bronchiolitis score chanced by percentage from baseline (time frame: day 5). The study lists 5 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 1 Jul 2026.