JADE101 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effects of a new treatment called JADE101 in healthy volunteers. The researchers focus on how the body absorbs, processes, and responds to a single dose of JADE101. Participants will receive the treatment through a subcutaneous injection (under the skin). The trial seeks healthy Japanese or Chinese individuals who have never smoked heavily and do not use drugs or alcohol excessively. As a Phase 1 trial, this research explores how JADE101 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the JADE101 trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that JADE101 is likely to be safe for humans?
Research has shown that JADE101 is safe for both healthy individuals and those with IgA nephropathy, a kidney disease. Studies found that JADE101 is generally well-tolerated, with no serious side effects observed in early preclinical tests. These studies tested a wide range of doses, and even the highest doses did not cause major problems in animals. This suggests that JADE101 is likely safe for humans, but ongoing studies will provide a clearer understanding.12345
Why do researchers think this study treatment might be promising?
JADE101 is unique because it introduces a novel approach by using a subcutaneous injection, which might enhance how the body absorbs the treatment compared to traditional oral medications. Unlike standard treatments that generally involve oral pills or topical applications, this injectable method could potentially offer more direct and efficient delivery of the active ingredient. Researchers are excited about JADE101 because it could represent a breakthrough in how quickly and effectively treatments act, possibly leading to better patient outcomes in less time.
What evidence suggests that JADE101 could be effective?
Research has shown that JADE101 has potential in early studies by significantly reducing proteins like IgA and IgM, often linked to conditions such as IgA nephropathy. This suggests that JADE101 might help manage diseases involving these proteins. Although these findings are promising, they originate from lab or animal studies, not human trials. The current trial will focus on understanding how JADE101 works in the body and its safety for people, providing more insights into its effectiveness. Further studies are needed to confirm these early results in humans.13467
Who Is on the Research Team?
Li Li, MD
Principal Investigator
Jade Biosciences
Are You a Good Fit for This Trial?
This trial is for healthy Japanese or Chinese adults aged 18-55, born in Japan or China, with a BMI between 18.0 and 32.0 and weight between 40-100 kg. Participants must not have major health issues, substance abuse history, be pregnant/nursing, or have significant allergies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of JADE101
Follow-up
Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics
What Are the Treatments Tested in This Trial?
Interventions
- JADE101
Trial Overview
The study tests a single dose of JADE101 to see how safe it is and how the body processes it in healthy Japanese and Chinese volunteers. It’s an early-phase (Phase 1) clinical trial.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subcutaneous (SC) injection of JADE101
Subcutaneous (SC) injection of JADE101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jade Biosciences, Inc.
Lead Sponsor
Citations
Jade Biosciences Presents New Data Demonstrating a ...
JADE101 is currently being evaluated in a Phase 1 healthy volunteer trial, with interim data expected in the first half of 2026 that is ...
A Phase 1 Study of JADE101 in Healthy Participants
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE101 ...
3.
biospace.com
biospace.com/press-releases/jade-biosciences-reports-first-quarter-2026-financial-results-and-provides-corporate-updateJade Biosciences Reports First Quarter 2026 Financial ...
Biomarker-rich interim data from the Phase 1 healthy volunteer study of JADE101 to be presented in an oral session at the 63rd European ...
EX-99.1
JADE101 Phase 1 healthy volunteer trial ongoing; biomarker-rich interim data expected in the first half of 2026. •. Phase 2 clinical trial of ...
5.
ctv.veeva.com
ctv.veeva.com/study/a-phase-2-study-of-jade101-in-participants-with-immunoglobulin-a-nephropathyA Phase 2 Study of JADE101 in Participants With ...
This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results ...
6.
journals.lww.com
journals.lww.com/jasn/fulltext/2025/10001/nonclinical_safety_profile_of_jade101,_a_half_life.2908.aspxNonclinical Safety Profile of JADE101, a Half-Life Extended ...
Evaluation of anti-APRIL therapies has consistently shown a favorable safety profile in healthy volunteers and IgAN patients. JADE101 is a fully human anti ...
7.
finance.yahoo.com
finance.yahoo.com/news/jade-biosciences-presents-data-demonstrating-160000794.htmlJade Biosciences Presents New Data Demonstrating a ...
JADE101 was well tolerated in NHPs at all doses tested preclinically, including the highest dose evaluated in GLP toxicology studies, which was ...
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