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New exosome drug tested in humans for first time – safety first

NCT ID NCT07219940

Knowledge-focused Sponsor: Shine-On Biomedical Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new drug called SOB100, which uses tiny particles called exosomes to target a protein named HLA-G. The study involves 15 healthy adults to check if the drug is safe and how the body processes it. No treatment benefit is expected; the goal is to gather safety information for future research.

What this could mean

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

Active substance
SOB100 (HLA-G-targeted exosome)

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 15 people

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

Started

Dec 2025

Expected to finish

Mar 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

18 years and older

Sex

Anyone

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: 1. Male or female subjects aged ≥ 18 years old 2. Overtly healthy subject, who is considered to be generally healthy based on medical history, 12-lead ECG, and physical examinations, as judged by the Investigator 3. Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF) 4. Adequate organ function Exclusion Criteria: 1. With known or suspected to be hypersensitivity to HLA-G related treatment. 2. Confirmed active HIV, HBV, or HCV infection 3. With active fungal, bacterial, viral or atypical infection requiring systemic medication 4. History of cancer (malignancy) or have ever received any anti-cancer therapy 5. Has ever received cell therapy or organ transplantation 6. Substance abuse or addictive use of drugs for nonmedical purposes 7. Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception 8. Male subjects with a female spouse/partner who is of childbearing potential refuse to adopt at least one highly effective method of contraception

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As listed by the trial registrant

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

Exosome Healthy subjects Targeted therapy

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

  • Parexel International - Baltimore Early Phase Clinical Unit

    RECRUITING

    Baltimore, Maryland, 21225, United States

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