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Inhaled interferon could be new weapon against severe RSV in young children

NCT ID NCT06363370

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether an inhaled solution of human interferon α1b can safely help children under 2 years old recover from respiratory syncytial virus (RSV) lower respiratory tract infections. The study compares the interferon treatment to a placebo, measuring improvements in breathing difficulty and other symptoms. Around 322 children will participate to see if this approach speeds up recovery and reduces illness severity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human interferon α1b inhaled solution
What this could lead to
If effective, this inhaled treatment could provide a safe, targeted way to help young children recover faster from serious RSV lung infections.
What could go wrong
This is an early-phase trial with a moderate number of participants. The treatment may not prove more effective than placebo, and side effects from interferon are possible.
Why investors are watching

Kexing Biopharm is running a phase III trial of its inhaled interferon drug, GB05, in 322 children under 2 years old with respiratory syncytial virus (RSV) infection. This is a late-stage, placebo-controlled study, and for a small company, the outcome of this single trial will largely determine the drug's commercial future. A positive result could lead to a regulatory approval application, while a negative one would likely end the program.

If it works: If the trial shows the drug is safe and effective, Kexing could seek approval to sell it as a treatment for RSV in young children. That would give the company its first marketable product and a potential revenue source.

If it fails: Phase III trials often fail, and this one could show the drug does not work better than placebo or has safety problems. A failure or a delay in the readout would likely hurt the company's prospects, as it has few other assets mentioned.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 322 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 months to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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; 2. 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. Exclusion Criteria: 1. 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); 2. Do not tolerate atomization inhalation to the administrator or suffer from severe oral and/or maxillofacial deformities, which affects the use of atomization inhalation; 3. Those who have genetic metabolic diseases; 4. A child with other respiratory pathogen infections (judgment based on the test results of respiratory pathogen); 5. 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; 6. There are severe cardiovascular (such as severe congenital heart disease, myocardial disease), the history of liver, kidney, and hemophilia. 7. There is a history of autoimmune diseases, such as autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, mixed connective tissue disease, dermatitis, etc.; 8. Those who are accompanied by basic diseases such as lung, bronchium, bronchial dysplasia; 9. Candid's with functional disorders and lesions with epilepsy or other central nervous system, such as meningitis, toxic or hypoxic encephalopathy; 10. During the filter, it is accompanied by severe diarrhea, moderate malnutrition, anemia, and blood system disease; 11. During the screening, the thoracic effusion, pydion and pus, and pus, etc.; 12. Merce able goose sores suspected mold infection during screening; 13. 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; 14. Extremely irritable, drowsiness, coma, or those who may need ventilator to assist breathing; 15. 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; 16. In the random 30 days before the randomly participated in any drug clinical trial or those who used research drugs; 17. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital, Capital Institute of Pediatrics

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.