40 Participants NeededMy employer runs this trial

JADE101 for Healthy Volunteers

H
Overseen ByHan
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Jade Biosciences, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

LL

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

First-generation Japanese or Chinese participants born in Japan/China
Willing and able to comply with contraceptive and lifestyle requirements from admission through the end of the study
Willing and able to comply with the study site stay, scheduled visits, and study procedures
See 2 more

Exclusion Criteria

Harmful alcohol use
Smoking/vaping or heavy tobacco use within 2 years prior to screening
Known history of abuse of illicit drugs
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of JADE101

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and pharmacodynamics

48 weeks
Multiple visits (in-person and virtual)

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

Group I: JADE101 Groups 3 and 4Experimental Treatment1 Intervention
Group II: JADE101 Groups 1 and 2Experimental Treatment1 Intervention

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 ...

Jade 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 ...

A 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 ...

Nonclinical 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 ...

Jade 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 ...