SOB100 for Healthy Individuals

(αHLA-G Exo-01 Trial)

Overseen By Oscar Yang

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Shine-On Biomedical Co., Ltd.

Must not be taking: Systemic anti-infectives

Disqualifiers: HIV, HBV, HCV, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SOB100 to assess its safety and how the body processes it. SOB100 targets a specific protein, HLA-G, involved in immune system regulation. The study seeks healthy adults who feel well and have no major health issues or infections. Participants must follow study procedures and have good organ function. This trial helps researchers learn more about SOB100's effects in healthy individuals. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that SOB100 is likely to be safe for humans?

Research has shown that SOB100 is under study to assess its safety and tolerability. Initial studies involve healthy participants to observe their bodily responses. As a Phase 1 study, the primary goal is to evaluate safety and identify any side effects.

In these early studies, researchers closely monitor for side effects or adverse reactions. Although specific data from past tests on SOB100 is unavailable, Phase 1 trials aim to identify potential risks and ensure the treatment's general safety. This phase is crucial for understanding the initial safety of SOB100. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SOB100 is unique because it introduces a novel mechanism of action, targeting pathways that current treatments for the condition may not address. Unlike existing options, which typically rely on [standard mechanisms], SOB100 works by [new mechanism], potentially offering a more targeted approach. Researchers are excited about SOB100 because it could lead to more effective and faster outcomes, with fewer side effects, for people managing this condition.

What evidence suggests that SOB100 could be effective?

Research has shown that SOB100, the treatment under study in this trial, has promising results in early studies. It targets a protein called HLA-G, often found in cancer cells, using a tiny molecule known as a nanobody. This method proved effective in animal studies of aggressive cancers, such as breast cancer. SOB100 can also cross the blood-brain barrier, a major challenge in treating brain conditions. Although human studies provide limited information, these early results suggest it could effectively treat difficult cancer types. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who can participate in a study to test the safety and effects of a new drug called SOB100. The study will look at how the body processes the drug and what doses are tolerable.

Inclusion Criteria

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

Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF)

I am 18 years old or older.

Exclusion Criteria

With known or suspected to be hypersensitivity to HLA-G related treatment

I am currently on medication for a serious infection.

I have had cancer or received cancer treatment before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SOB100 in a dose-escalation format to evaluate tolerability, safety, and pharmacokinetics

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SOB100

Trial Overview SOB100, an HLA-G targeted exosome with a nanobody attached, is being tested. This early-phase trial aims to determine safe dosage levels and understand how the drug behaves in the body (pharmacokinetics).

How Is the Trial Designed?

Group I: SOB100 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Shine-On Biomedical Co., Ltd.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219940

A Study to Investigate HLA-G Targeted Exosome (SOB100) ... The investigational drug, SOB100, is an HLA-G targeted exosome equipped with a nanobody namely anti-HLA-G VHH on the exosome membrane. This is a Phase I dose ...

2. cmuh.cmu.edu.tw cmuh.cmu.edu.tw/NewsInfo/NewsArticle?no=9480

World's First HLA-G Targeted Exosome Therapy for Cancer ... The novel platform, named SOB100, has completed preclinical studies and demonstrated promising efficacy in treating aggressive cancers such as breast cancer ...

3. clinconnect.io clinconnect.io/trials/NCT07219940

A Study to Investigate HLA-G Targeted Exosome (SOB100) Who can join: Adults 18 and older who are generally healthy, able to understand and sign consent, and have normal organ function. Exclusion criteria include ...

4. biopharmaapac.com biopharmaapac.com/report/31/6560/taiwan-steps-into-the-global-spotlight-with-a-new-cancer-therapy.html

Taiwan Steps Into the Global Spotlight With a New Cancer ... Animal studies have shown that SOB100 works well in tough cancer models. It even crosses the blood-brain barrier with minimal drug loss ...

5. prnewswire.com prnewswire.com/news-releases/worlds-first-hla-g-targeted-exosome-therapy-for-cancer-enters-us-clinical-trials-302476389.html

World's First HLA-G Targeted Exosome Therapy for ... The novel platform, named SOB100, has completed preclinical studies and demonstrated promising efficacy in treating aggressive cancers such as breast cancer ...

6. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-f9f47

SOB100 for Healthy Individuals (αHLA-G Exo-01 Trial) This trial is for healthy individuals who can participate in a study to test the safety and effects of a new drug called SOB100. The study will look at how the ...

7. synapse.patsnap.com synapse.patsnap.com/drug/e776dde8af1b41bfbf57db2c69bee22c

SOB-100 - Drug Targets, Indications, Patents An Open-label and Dose-escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of HLA-G-targeted ...