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New enzyme drug tested in healthy volunteers

NCT ID NCT07484893

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial will test a new drug called recombinant human hyaluronidase in 24 healthy Chinese men. The drug is an enzyme that may help other medications spread more easily under the skin. The main goal is to check safety, how the body processes the drug, and whether it causes an immune response.

What this could mean

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

Active substance
recombinant human hyaluronidase
What this could lead to
If successful, this could help develop a drug that helps other medications spread more easily under the skin.
What could go wrong
This is a very early, small trial in healthy volunteers, so it won't test any disease treatment. The drug may cause allergic reactions or injection site issues.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

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

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy male subjects, aged ≥ 18 and ≤ 45 years. * Body Mass Index (BMI) ≥ 18.0 and ≤ 28.0 kg/m². * Intact skin at the injection site, with no damage, tattoos, or other markings. * No significant medical history, or a history of abnormalities that, in the investigator's judgment, will not impact the study. * Physical examination, vital signs, electrocardiogram (ECG), chest X-ray, and clinical laboratory tests are normal or abnormal without clinical significance (NCS). * Subjects must agree to use highly effective contraception with their spouse or partner from the time of signing the Informed Consent Form (ICF) until 3 months after the last dose, or the subject is not capable of reproduction. Subjects must also refrain from sperm donation during the study and for 3 months following the last dose of the investigational product. * Voluntarily signed the Informed Consent Form (ICF) prior to any study procedures, with a full understanding of the study content, procedures, and potential adverse events (AEs); and the ability to comply with the protocol requirements to complete the study. Exclusion Criteria: * History of drug abuse or or substance use, or a positive drug screen; history of long-term heavy alcohol consumption (defined as consuming more than 14 units of alcohol per week within 3 months prior to screening \[1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine\]) or a positive blood alcohol test; history of long-term heavy alcohol use or positive blood alcohol test; history of long-term heavy smoking (defined as an average of more than 5 cigarettes per day within 3 months prior to screening, or inability to abstain from smoking during the ). * Cardiac disorders, including but not limited to clinically significant ECG abnormalities during the screening period, QTcF \> 450ms, or a history of clinically significant ECG abnormalities. * History of any clinically severe hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or oncological diseases, or allergic diseases. * History of upper respiratory tract infection or other acute infections within 7 days prior to the first dose, or systemic use of antibiotics within 7 days. * Known allergy to recombinant human hyaluronidase for injection or its formulation components; history of severe allergic reactions to any medication (e.g., angioedema); special dietary requirements or inability to comply with the standardized diet provided by the clinical site. * Use of any prescription drugs, over-the-counter (OTC) medications, or herbal medicines within 4 weeks prior to screening (especially salicylates, cortisone, adrenocorticotropic hormone, estrogens, or antihistamines, except for routine vitamin supplements), or within 5 half-lives of the medication (whichever is longer). * Vaccination within 1 month prior to administration. * History of blood donation or blood loss ≥ 400 mL within 3 months prior to the use of the investigational product. * Participation in any other clinical study and use of investigational/control products within 3 months prior to the investigational product administration. * Positive for HBsAg, anti-HCV, anti-HIV, or the syphilis spirochete test. * Sensory-motor disorders or autonomic movement disorders. * Any condition which, in the investigator's judgment, would make the subject unable to comply with the protocol requirements, instructions, or study restrictions, such as an uncooperative attitude, inability to return for follow-up visits, or inability to complete the study.

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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

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Contacts and locations

Locations

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

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