SOB100 for Healthy Individuals
(αHLA-G Exo-01 Trial)
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 SOB100.12345Why 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.13567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SOB100 in a dose-escalation format to evaluate tolerability, safety, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shine-On Biomedical Co., Ltd.
Lead Sponsor
Citations
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 ...
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 ...
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.htmlTaiwan 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.htmlWorld'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 ...
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 ...
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 ...
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